Patent Publication Number: US-2023152337-A1

Title: Analysis Device

Description:
This invention relates to an analysis device, for example suitable for use in conducting DNA and/or RNA analysis. In particular, it relates to a device that does not require a significant supporting infrastructure and so makes it possible to perform high quantity, high-integrity biological analyses “in the field” or away from a laboratory, if desired, although the invention is not restricted to such use and may be used in other applications or environments. 
     Where analysis tasks are required to be undertaken, currently the analyst typically has to transport large quantities of equipment to the field to allow the analysis to be performed. The level of equipment required is such that this task can be challenging and impractical. Alternatively, samples to be analysed may be transported to a remote laboratory for analysis. The remote laboratory approach involves local sampling and then sample transportation to a central laboratory facility, and this approach introduces delays in obtaining results and cross-contamination risks into the process. The delays may result in required tests not being completed before goods are shipped, for example, and so raises the risk of unnecessary process, commercial, business or other impacts, and the cross-contamination risks reduce analysis accuracy and raise the chance of erroneous false-positive results being returned. 
     Where the analysis is used to test individuals for specific biological infections such as  E. coli, C. difficile  or coronavirus (COVID-19), the typical analysis regimes can take over 48 hours to obtain a result, during which time the risks may have spread. 
     There are currently no reliable analysis techniques that permit an unskilled or semi-skilled operator to sample and accurately analyse biological targets “in the field” in a short space of time. The biggest issue in conventional analysis techniques is the handling of the assay reagent and the sampling process for the target to be analysed. 
     There is a need for an analysis technique and an analysis device for use therein which can efficiently and accurately provide an analysis result within a short period of time. There is a need for an analysis technique which can be safely and effectively carried out by an unskilled or semi-skilled operator. One objective of the invention to provide such a device and technique, in which at least some of the disadvantages associated with known techniques and devices are overcome or are of reduced impact. 
     According to a first aspect of the present invention, there is provided an analysis device comprising a housing, and a carrier located within the housing, the carrier including a plurality of individual pockets, each pocket containing a stable assay reagent material, and a first seal member positionable over at least one of the pockets to substantially seal the said pocket(s). 
     The carrier conveniently comprises a reel-to-reel tape. Alternatively, it may comprise a rotatable disc. The first seal member conveniently comprises a tape that can be applied to the carrier to substantially seal the pockets thereof, in turn. 
     The assay device preferably further comprises a second seal member. The second seal member conveniently comprises a tape that can be removed from the carrier to uncover the pockets thereof, in turn. 
     The carrier is preferably moveable relative to the housing. The housing is preferably provided with an access window, and the carrier is preferably movable to register or align the pockets thereof, in turn, with the access window to allow target samples to be introduced into the pockets, in turn. A movable shutter is preferably provided and operable to close the access window and prevent or restrict access to the interior of the housing. 
     Preferably, the second seal member is removed from each pocket before, preferably immediately before, that pocket is moved into alignment with the window. In this manner, the assay reagent material within each pocket can be kept under sterile and/or other preferred storage conditions until the point at which the target sample is introduced thereto. 
     Preferably, the first seal member is applied to each pocket after, preferably immediately after, movement of that pocket away from the window. In this manner, the target sample introduced into the pocket is stored in a sealed manner, and so presents minimal risk to an operator or other personnel in the vicinity of the assay device. 
     A shield device is preferably provided and arranged to be fitted to the device, to guide the introduction of the target sample into the pocket and protect the surrounding parts of the device from contamination. Where a swab is used in the introduction of the target sample, the shield device conveniently becomes attached to the swab upon the introduction of the target sample so that the shield device is removed from the device, in use, with the swab. 
     According to a second aspect of the present invention, there is provided an assay testing method comprising providing an analysis device as set out hereinbefore, moving the carrier to a first position providing access to a first pocket thereof, depositing a target sample within first pocket, and moving the carrier to a second position, wherein upon movement of the carrier to the second position the first seal member is applied to close and substantially seal the first pocket. 
     It will be appreciated that the invention provides an apparatus which enables a stable assay reagent material to be stored in pockets within the carrier prior to exposure to a target sample. The apparatus ensures that the assay reagent material is preserved in the pockets prior to exposure to a target sample. 
     As set out hereinbefore a contamination shield device is preferably provided and used to aid the introduction of the target sample into the first pocket and to avoid contamination of surround parts of the device. 
     The sample treated assay pocket may be stored successfully for a period of time prior to analysis as the treated assay pocket is sealed from an external environment by the first seal member. During analysis, the test sample treated assay pocket is analysed to confirm the presence or absence of the target contaminant. This may be undertaken with the first seal member still in position, so exposure of a target sample need not occur. 
     The apparatus may be configured to carry out single or multiple tests which can be successfully stored within a single housing. By way of example, tests conducted upon a number of individuals may all be contained within a single housing. 
     The analysis apparatus provides a controlled mechanism for delivering a stable assay for exposure to a test sample when required. It enables effective end-to-end sampling and analysis process. 
     The apparatus is simple and easy to use enabling the apparatus to be handled by unskilled operators. 
     The apparatus, for example the housing, may further comprise a protective cover, in the form of for example a protective shutter, operable to prevent access to the interior of the housing. 
     The first and/or second seal member may, in one embodiment, be applied by exposure to heat, for example a heat stamp. An adhesive may be applied to a portion of the pocket, for example. The adhesive may be heat activated. 
     The pockets may be accessed by an operator securely and without risk of cross-contamination. The test sample may be easily introduced into the recess of the pocket and applied to the assay stored therein. The test sample may be treated according to the specific assay type and process to reveal the DNA and RNA. 
     An analyser unit may be provided for use in conjunction with the assay device. 
     The analyser unit may be configured to detect DNA and RNA within the test sample, if present, by illuminating the sample with light at the appropriate wavelength and monitoring the sample for release of light at the characteristic frequency of the contaminant being sought. The emitted light intensity is recorded for the duration of the process and then uploaded to an attached computer or smartphone where it is examined to determine whether or not the contaminant is present and, if it is, the rate of increase of its population. 
     The method of analysis of the present invention may further comprise use of the analyser unit for determining presence of a contaminant within a pocket. 
     The apparatus may further comprise a transmitter configured to transmit analysis information data to a receiver configured to receive the analysis information data and to process the received analysis information data. The receiver may be configured to relay the received analysis information data to another system for onwards communication, for example to a nearby office, security station or other facility to support the provision of a response to the analysis information data results. 
     The analyser unit may communicate with the smartphone or computer using standard communications techniques including Bluetooth®, Wi-Fi® or other short-range communications technique. 
     The apparatus may further comprise additional electronic systems configured to gather suitable data on the local environment and location and a) to retain that data in a secure repository and/or b) to relay suitable information to a third party for possible action using standard communications, web-based systems or modern Android®, Apple® or other applications (“Apps”). This data may be uploaded to the central database at the earliest opportunity to provide a detailed, searchable history of all measurements in one or multiple fields. 
     The analyser unit may be a biological sample processing unit. 
     The assay device may contain a dry-preserved assay reagent located within one or more pockets of the carrier. 
     The analyser unit may comprise an optical transmitter and receiver in communication with each other, in which the analyser unit is configured in use to energise and detect a biological target. 
     The analyser unit may further comprise a display configured in use to show the results from the transmitter and/or receiver. The analyser unit may be operable to share the result with a smartphone or computer. 
    
    
     
       The invention will further be described, by way of example, with reference to the accompanying drawings, in which: 
         FIG.  1    is a view illustrating an analysis device in accordance with an embodiment of the invention; 
         FIG.  2    is a diagram illustrating parts of the analysis device; 
         FIG.  3    is a diagrammatic representation of an analyser unit in use in conjunction with the analysis device; and 
         FIG.  4    is a series of views illustrating part of the device, in use. 
     
    
    
     Referring to the accompanying drawings, an analysis device  10  in accordance with an embodiment of the invention is illustrated, the device  10  comprising a housing  12  defining a cavity, and a carrier  14  located within the cavity. The carrier  14 , in this embodiment, comprises a reel-to-reel tape  16 , but it will be appreciated that the invention is not restricted in this regard and could take other forms. By way of example, it could be of disc-shaped form. The tape  16  is shaped to define a plurality of discrete open pockets  18 , opening to a face of the tape  16 , each pocket  18  comprising a recess containing a stable assay reagent material (not shown). The nature of the assay reagent material will depend upon the type of test or analysis being undertaken and is not of relevance to the present invention and so is not described herein in further detail. 
     The device  10  further comprises a first seal member  20  that is operable, in use, to substantially seal at least some of the pockets  18 , and a second seal member  26  that, similarly, is operable, in use, to substantially seal at least some of the pockets  18 . The seal members  20 ,  26  conveniently take the form of tapes of a suitable flexible material that can be adhered or otherwise secured to the tape  16  to close and seal the pockets  18 . 
     The tape  16  is prepared (typically elsewhere) with the reagent material located within the pockets  18 , and with the second seal member  26  affixed to the tape  16  to seal the pockets  18  with the assay reagent material located therein. Whilst the pockets  18  may all contain the same assay reagent material, this need not always be the case, and certain of the pockets  18  may include different assay reagent materials, for example to serve as controls, or to allow a series of different tests or the like to be performed. 
     The tape  16  is moveable relative to the housing  12  past an access window  22  formed in the housing  12  so as to align the pockets  18 , in turn, with the access window  22 . A shutter  24  is moveable attached to the housing  12  and is moveable between a closed position in which it closes the access window  22 , and an open position. 
     The tape  16  is wound upon and extends between reels  16   a ,  16   b  and passes adjacent the access window  22 . As illustrated, the housing  12  conveniently includes openings  28 ,  30  through which parts of the seal members  20 ,  26  project. The pockets  18  in the parts of the tape  16  wound onto the reel  16   a  and between the reel  16   a  and the opening  30  are sealed by the second seal member  26 , as mentioned hereinbefore. Similarly, the pockets  18  in the parts of the tape  16  wound onto the reel  16   b  and between the reel  16   b  and the opening  28  are sealed by the first seal member  20 . The pockets  18  in the part of the tape  16  between the openings  28 ,  30  are uncovered in the sense that they are not closed and sealed by either of the first and second seal members  20 ,  26 . These pockets  18  are, however, contained within the housing  12 , and so access thereto is restricted. 
     In use, when a user has a target sample ready for analysis, the shutter  24  is opened, and the user loads the target sample into the pocket  18  immediately adjacent the window  22 . The shutter  24  is then closed. 
     As shown in  FIG.  4   , the step of loading the target sample into the pocket  18  conveniently includes fitting a shield device  32  into the window  22  which serves to guide the introduction of a swab or the like through the window  22  and into the pocket  18 , whilst also shielding or protecting the adjacent parts of the device  10  from contamination. Upon full introduction of the swab or the like into the pocket  18 , the shield device  32  conveniently becomes attached to the swab or the like, so that upon subsequent removal of the swab or the like, the shield device  32  is removed from the device  10 . As illustrated, the shield device  32  is of generally funnel like form, including an opening  34  through which the swab is exposed, in use, when fully inserted, to the contents of the pocket  18 . 
     Once the sample is received within the pocket  18 , the reels  16   a ,  16   b  are rotated, for example using suitable stepper motors, to move the tape  16  to bring the next one of the pockets  18  into alignment with the window  22 . During such winding, part of the seal member  20  is introduced into the housing  12  through the opening  28  to overlie the pocket  18  that newly contains the target sample, and is sealed to the tape  16  to close and seal that pocket. By way of example, this may be achieved using a heat stamp to activate a heat activated adhesive applied around the pocket  18 , for example. An alternative option may be to heat weld the seal member  20  in position. It will be appreciated that other techniques may be used without departing from the scope of the invention. The contents of the pocket  18  containing the newly introduced target sample are thus substantially sealed from the external environment, reducing or avoiding the risk of contamination and so enhancing test accuracy, and also providing protection for the user and others in the vicinity of the device. 
     The newly sealed pocket  18  may thus be moved to a storage position within the housing  12  of the device, becoming wound upon the reel  16   b.    
     In addition, the movement of the tape  16  allows removal, for example by unpeeling, of part of the seal member  26  from part of the tape  16 , thus exposing the next one of the pockets  18  to be aligned with the window  22 , ready for introduction of the next sample. 
     The analysis device conveniently further comprises an analyser unit (see  FIG.  3   ). The housing  12 , after having been loaded with samples to be analysed, may for example be inserted into the analyser unit  40 . 
     The analyser unit  40  is conveniently configured to read the assay material type and reports this information to a computer program or application (referred to herein as an “App”). The App may be configured to initiate a test sequence based upon this information, the test sequence requiring inputs such as the sample and target details. 
     The sealed pocket  18  is moved to an analysis point to enable analysis of the contents of the pocket  18 , for example along with the positive and negative control pockets. 
     The analyser unit  40  conveniently includes heat plates  42  adjacent which the pockets  18  are passed to heat or cool the pocket contents to a desired temperature and/or to hold the pocket contents at that temperature for a predetermined dwell time. In a simpler arrangement, a single heat plate may be used to raise the temperature of the contents of the pockets  18  to allow the performance of omnithermal tests. Subsequently, the pockets  18  are illuminated, in turn, using a light source  44  of a predetermined wavelength, and the fluorescence from the pockets is measured by a detector  46 . The data derived in this manner may indicate whether target is present in the sample and, if so, the concentration of the target using the amount of light emitted at the characteristic wavelength. This illumination and fluorescence measurement may be repeated at various time points, determined by the nature of the test or analysis to be performed, to determine whether or not the target is present and, as the light output increases, the point at which it crosses thresholds. 
     The analyser unit  40  may include a transmitter configured to transmit the analysis information data to a remote receiver configured to receive the analysis information data, and to process the received analysis information data. The receiver may be configured to relay the received analysis information data to another system for onwards communication, for example to a local computer, nearby office or other facility to support the provision of a response to the received analysis information, if required. This may be delivered directly, for example through a computer network, or through a web server, or through an Android™- or Apple™-style smart-phone application. 
     In one mode of operation, therefore, the target assay analyser unit  40  may receive the analysis apparatus housing  12  and operate to recognise the assay type. The unit  40  communicates with the App and they confirm that the correct analysis process is loaded. The App then directs data entry, the sampling and sample application to the assay. Once loaded, the unit automatically processes the sample using one or more of the heat plates and stepper motors or the like to drive the reels for rotation, and communicates the results to the App. 
     The App configures the data and uploads this to a central database when the network is available. 
     The uploaded data may include user data from the App, location data from the device, along with temperature and humidity readings and other parameters, to enrich the data. 
     The analyser unit  40  may be deployed singly or as a networked sensing system. In this case the system may be connected to the end user in a number of ways. This includes the network interface to port data into the network for a single or multiple analyses. It also includes the application that is required at the user or owner site to receive and display relevant information and this will be in the form of an application (on a smart-phone or tablet) or a web service or a bespoke display. 
     Whilst a specific embodiment of the invention is described hereinbefore, it will be appreciated that a wide range of modifications and alterations may be made thereto without departing from the scope of the invention as defined by the appended claims.