Patent ID: 12214351

DETAILED DESCRIPTION OF THE INVENTION

The invention provides a reduced volume developer solution vial for collecting samples for use with an assay device, and methods of use that simplify and make more efficient diagnostics of respiratory diseases, including a number of viruses (approximately 80% of all respiratory diseases being viral) such as influenza A and B viruses, parainfluenza virus (PIV) type 1 (PIV1), PIV2, PIV3, respiratory syncytial virus (RSV), adenovirus, rhinovirus, avian influenza viruses (H5N1, H7N7, and H7N3), human metapneumovirus (hMPV), severe acute respiratory syndrome (SARS), coronavirus (COVID-19), bocavirus, enterovirus, PIV4, parvovirus types 4 and 5, and mimivirus all affect the respiratory tract. Although discussed below in view of exemplary embodiments of the invention that may refer specifically to COVID-19, the invention may be used for any number of sampling collection methods for disease diagnosis, including, for example, sample collection by swabbing from surfaces or a patient's bodily fluid. Although the description of the invention may refer specifically to nasal sample collection, the collection of samples may include saliva sampling, other sampling of bodily fluids, or sampling from surfaces. The invention may generally be used in a point-of-care sample collecting and rapid testing method via low-volume fluid flow assay testing.

COVID-19 Lateral Flow Assays

Immunoassays are being employed on the front-lines to determine whether or not a person has COVID-19 or been exposed to it. Positive results from an immunoassay indicate the presence of SARS-1 and SARS-2 Nucleocapsid Antigen. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results are presumptive and require additional testing to confirm the presence of SARS-CoV-2 antigens that cause COVID-19 disease. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not preclude SARS-CoV-2 infection and are not used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

A developer solution vial of the invention may be used with a LFA device to test for COVID-19. Such a LFA device typically has a collection pad used in a COVID-19 rapid antigen test as an in vitro diagnostic single-use immunoassay for qualitative detection of SARS-1 and SARS-2 Nucleocapsid Antigen in nasal sample collected from the anterior nares in individuals who meet the COVID-19 clinical and/or epidemiological criteria.

Developer Solution Vial

FIG.1A-1Cshow exemplary top, top perspective, and top-side perspective view illustrations of a developer solution vial for use with an assay device, of the invention. The developer solution vial100is keyed to and used with sampling devices and assay devices for use in diagnostics testing for a respiratory disease. The sampling devices may include swabs and other applicators. A swab may include a cotton swab or flat swab with different shapes and sizes. The assay devices may include LFAs or other fluid assay devices. In some embodiments, the sampling device, such as a rigid capillary matrix, is integrated into the assay device to reduce the number of devices used and steps required for diagnosis. Although the sampling devices described below may reference a swab, any sampling device may be used and appropriately fitted or keyed to the developer solution vial100so that the two mate.

The developer solution vial100may be a single piece device or fit together as an insert with a defined cavity101and elongated housing102including a mating portion131(see, e.g.,FIG.3A) for interfacing with sampling and assay devices. The housing102may include any number of outer shapes and sizes, such as a cylinder, rectangular prism, triangular prism or other prism shapes including star shaped, or other asymmetrical shape prisms. The housing102includes an opening106extending to cavity101. However, the cavity101, in an exemplary embodiment, is reduced in volume to minimize the dilution of a collected sample. The volume of the cavity may range from 75 to 1500 microliters (μL). In some embodiments, the volume of the cavity is preferably between 450 and 850 μL. In some embodiments, the volume of the cavity s preferably between 600 and 750 μL. The cavity101may contain a stabilizing developer solution. The volume of developer solution is between 50 and 1000 microliters. In some embodiments, the volume of developer solution is preferably between 300 and 450 microliters. In some embodiments, the volume of developer solution is preferably between 400 and 450 microliters. The elongated housing102includes, surrounding the cavity101, a mating portion131. The mating portion131includes extraction portion103aand103b, seating portion105, and sidewall portion107, sampling device interface portion109, and guiding wall portion111.

The extraction portion103aand103bprotrudes from the sampling device interface portion109toward a center of the cavity101. The exemplary extraction portion103aand103bshown in the figure has a rounded semi-circular cross-sectional shape that protrudes into the cavity101. The extraction portion103aand103baids in the recovery of collected sample and developer solution which remains in a swab as the swab is removed from the developer solution vial100. Each pass of the swab through the extraction portion103aand103bmay recover more collected sample from the swab. Because swabs generally include a circular shape, the sampling device interface portion109and the extraction portion103generally have a circular shape and is sized just large enough to compress and allow the swab to enter the cavity containing the developer solution. In some embodiments, the extraction portion103aand103bmay be a single-piece unit with the rest of the developer solution vial100. In other embodiments, the extraction portion103aand103bis a separate part added to the developer solution vial100. The extraction portion103aand103bmay be shaped to engage with any particular sampling device and may also be considered a squeegee for the sampling device to recover sample from the sampling device for depositing into a developer solution in the developer solution vial100.

In some embodiments, the extraction portion103aand103bmay be a single continuous part in instances where the assay device is of a similar or same shape as the extraction portion103. In some embodiments, the extraction portion103may include a plurality of parts spread evenly around the perimeter of the cavity to provide even extraction of the sample from a sampling device. In some embodiments, the extraction portion103may include rough or abrasive features along the surface of the extraction portion103to aid in recovery of sample from the sampling device.

In some embodiments, the extraction portion103may include a protruding triangular shape or other shape that further promotes recovery of sample from the sampling device and developer solution that may remain on the sampling device. The extraction portion103may also promote entry into the cavity101by requiring a greater force from a user to remove the sampling device rather than insert the sampling device. This may be done through a biased or multiple inclined extraction portion that has a more gradual incline for insertion into the cavity101and a more drastic incline for removal to prevent accidental removal and aid in recovery.

The seating portion105is configured to allow the collection pad of an assay device to rest in the developer solution vial100. The seating portion105includes a mating surface to contact a resting surface of the housing or the collection pad of the assay device. The contacting surfaces allow the assay device to rest in the developer solution vial100without touching the both the bottom of the cavity101and sidewalls of the cavity101of the developer solution vial100which prevents compression. The resting surface may include one or more surfaces of an outer boundary of the assay device. In some embodiments, the resting surface includes a widest cross-sectional portion of the assay device near the collection pad. For example, as shown inFIGS.8A-D, the widened portion of the collection pad and housing provides a resting surface403for the assay device in the developer solution vial100. Thus, the mating surface generally contours with the resting surface of the assay device to place the assay device in a centered location when resting in the developer solution vial100.

The interior walls of the mating portion131help to define cavity101include the sidewall portion107, sampling device interface portion109, and guiding wall portion111. The sidewall portion107is configured to allow the front and back planar portions of the collection pad to be evenly placed in the developer solution vial100without compression of the collection pad. In some embodiments, the sidewall portion107may include contours to permit particular collection pads of a predetermined shape and size to interface with the developer solution vial100. The sidewall portion107provides structure to the cavity101to allow the collection pad to, when resting in the developer solution vial100, enter the cavity101and sit without touching the sidewall portion107. The sidewall portion107defines the cavity101to minimize the volume of developer solution in the developer solution vial100by providing a minimal space between the collection pad and sidewall portion107while still allowing sample to be drawn into the collection pad.

The interior walls of the mating portion131may generally include a slightly angled shape to guide any sampling device or assay in towards the center of the cavity101. Although separately depicted, the sampling device interface portion109may also be incorporated into the guiding wall portion111to further aid in the sample recovery and guiding of the sampling device into the developer solution stored in the cavity101. The sampling device interface portion109is contoured to the shape and size of a predetermined sampling device. In some embodiments, the sampling device is a swab with a circular shaped head and thus the sampling device interface portion109is also in a circular shape. The sampling device interface portion109may also define the shape of the extraction portion103aand103b, where the extraction portion103aand103bincludes a concentrically contoured surface to the sampling device interface portion109.

In the exemplary embodiment shown, the guiding wall portion111includes a smaller incline from vertical than the sampling device interface portion109. The guiding wall portion111is a much longer, longitudinally, portion than the sampling device interface portion109. As a sampling or assay device is guided into the developer solution vial100, the interior walls of the mating portion131begin to slowly force (with the guiding wall portion111), the sampling or assay device, in toward the center of a volume of solution contained in the bottom of the cavity101of the developer solution vial100, however as the cross-sectional area defined by the guiding wall portion111reduces, the sampling device will meet a extraction portion103aor103bwhich is slightly smaller than the width of a head of the sampling device. This forced contact with the extraction portion103aor103baids recovery of any samples collected on the sampling device into the developer solution through a compressive and/or friction force. The guiding wall portion111may begin between the opening106and a top edge of seating portion105to help guide the sampling or assay device into the developer solution vial without resting on the bottom of the developer solution vial100.

FIGS.2A and2Bshow exemplary bottom and bottom perspective view illustrations of a developer solution vial for use with an assay device, of the invention. The exemplary developer solution vial100may be injection molded or manufactured in other ways. An injection molded developer solution vial may include a contoured bottom interior corresponding to the cavity101, however, the base104provides the developer solution vial100a support to retain the sampling or assay device, when at rest, in an upright position. The sampling or assay device is retained longitudinal to the elongated housing102using the elongated housing102sidewalls and/or the bottom planar face of the vial100. The base104prevents tipping of the developer solution vial100when a sampling or assay device is rested in the developer solution contained in the developer solution vial100. When used in conjunction with a testing stand, the developer solution vial100is capable of retaining the sampling or assay device, when in a resting state, in a vertical or near vertical position to aid in user agitation of a sample in the developer solution and allow the assay device to drive (by wicking) the sample through the assay device on its own, i.e., through adsorption and capillary action.

FIGS.3A and3Bshow exemplary cross-sectional front and cross-sectional front perspective view illustrations of a developer solution vial for use with an assay device from section C-C of one embodiment of a developer solution vial ofFIGS.1A and2A, of the invention. The cross-sectional view shows longitudinal length of walls inside the cavity101more clearly. The sidewall portions107aand107bhelp to define a key-hole shaped opening holding the developer solution. The sidewall portions107aand107bare nearly vertical to guide the sides of an assay device into the cavity101. The sidewall portions107aand107bare from the bottom of the cavity101to an area near the extraction portion103aof the to help define the central part of the developer solution vial100, where the developer solution is contained and samples are collected and drawn. When in a resting position in the developer solution vial100, the sampling or assay device will rest on the seating portion105. Thus, the seating portion105is configured to mate with the side structure of a sampling or assay device to retain the device in an upright position in the developer solution vial100without user support. When resting, a head of the sampling or assay device (for sample collection and/or flow of sample into the assay) will preferably not be compressed by or touch the sidewalls and the bottom of the cavity to create consistent flow into the assay and enhance elution efficiency.

The guiding wall portion111may include multiple sections where a first section108, nearer the opening106, may include a more angled, from vertical, wall shape, and a second section110, nearer the top of the extraction portion105, may include a less angled, from vertical, wall shape. Although the developer solution vial100may depict the first section108to be shorter, longitudinally, than the second section110, any longitudinal length for each section that helps to guide sampling or assay devices into the cavity101may be appropriate. As long as the first section108is wider, cross-sectionally, than the second section110.

In some embodiments, the extraction portion103amay be located lower (closer to the bottom of cavity101) or higher (nearer the top of the seating portion105or even into the guiding wall portion111) in the cavity101. However, the position of the extraction portion103awould be based on the length of a head of the sampling device, and ideally remain below the top of the seating portion105to provide access to the extraction portion103awhile the sampling or assay device is submerged in the developer solution.

FIGS.4A-4Cshow an exemplary top, top perspective, top-side perspective view illustrations of a developer solution vial insert for use with an assay device of the invention. The developer solution vial insert200may include, as shown, cavity201and elongated housing202with mating portion231(see, e.g.,FIG.4H) for interfacing with sampling and assay devices. The mating portion231is keyed to the size and shape of the sampling and assay devices to be used. The mating portion231includes, extraction portion203aand203b, seating portion205, sidewall portion207, sampling device interface portion209, and guiding wall portion211. The mating portion231of the developer solution vial insert200surround cavity201and interface with sampling or assay devices. The mating portion231helps guide the sampling or assay device into the developer solution vial assembly (the assembled developer solution vial insert200and elongated housing) when in use. The mating portion231of the developer solution vial insert200define cavity201and guide the sampling or assay device into the developer solution vial assembly (the assembled developer solution vial insert200and elongated housing) when in use. The mating portion231have similar features as described by the developer solution vial100ofFIGS.1A-3Babove.

The developer solution vial insert200does not include outer sidewalls and thus more clearly shows the contoured shape for mating with predetermined sampling and assay devices.FIG.4Dshows an exemplary bottom view illustration of the developer solution vial insert ofFIGS.4A-4Cfor use with an assay device, of the invention. As shown, cavity201runs through the whole of the developer solution vial insert200with a base204on one end and the keyed opening top at the other end. The amount of developer solution required for use with the insert is then based on a corresponding container for which the developer solution vial insert200is combined. The corresponding container may include labware such as glass tubes, conical vials, or other container or enclosure. The corresponding portion of the corresponding container further defining the boundaries of the combined cavity (the cavity201and space between the base204and bottom of the corresponding container), and thus define the volume of developer solution used with the developer solution vial insert200. In some embodiments, the cavity201may be closed on the end with base204to further restrict the amount of developer solution needed to fill cavity201. However, the combined cavity is preferably sized to provide a specific minimized volume of developer solution for use. The cross-sectional width of the developer solution vial insert200is then predetermined to tightly fit the corresponding container to prevent additional developer solution from seeping out from any space between the developer solution vial insert200and the inside surface of the corresponding container.

FIGS.4E-4Gshow exemplary front, side, and side perspective view illustrations of a developer solution vial insert for use with an assay device, of the invention. As described inFIG.4Dabove, the base204of the developer solution vial insert200may not be closed. Instead, the cavity201of the developer solution vial insert200may be capped by an corresponding container. For example, the developer solution vial insert200could mate with an elongated cylindrical housing, open on one end and closed on the bottom. The base204would be placed and sealed, even with the closed bottom of the cylindrical housing to contain the developer solution. The top of the elongated cylindrical housing would extend beyond the guiding wall portion211to prevent accidental spillage of developer solution in the combined developer solution vial insert200and elongated cylindrical housing.

FIGS.4H and4Ishow exemplary cross-sectional front and front perspective view illustrations of the developer solution vial insert ofFIGS.4A-4Gfor use with an assay device from section D-D of one embodiment of the invention. Similar to the features inFIGS.3A and3B, the cross-sectional illustrations more clearly show the dimensions and shape of each portion of the developer solution vial insert200. For example, the guiding wall portion211includes a first section208, second section210, and third section212. Each section cross-sectionally narrows from the opening206of the developer solution vial insert200to the top of the seating portion205.

FIGS.5A and5Bshow exemplary top and top perspective view illustrations of the developer solution vial ofFIGS.1A-3Bfor use with an assay device of one embodiment of the invention.FIGS.5C and5Dshow exemplary cross-sectional front and cross-sectional front perspective view illustrations of the developer solution vial ofFIG.5Afor use with an assay device from section E-E of one embodiment of the invention. The developer solution vial100is filled with developer solution121. As shown, the developer solution121is filled to submerge the extraction portion103and submerge the top edge of the seating portion105and sampling device interface portion109. However, in some embodiments, the seating portion105remains above a fill-line and is not submerged in the developer solution. In some embodiments, the developer solution vial100includes a marked fill-line, in other embodiments, the developer solution vial100does not include a marking for the fill-line.

FIGS.6A and6Bshow exemplary top and top perspective view illustrations of a minimized developer solution vial for use with an assay device of one embodiment of the invention. The minimized developer solution vial300includes a cavity301and elongated housing302with mating portion331(see, e.g.,FIG.6E) for interfacing with assay devices. The mating portion331including seating portion305, sidewall portion307, and guiding wall portion311. The seating portion305is configured to mate with a shortened direct sampling device. The shortened direct sampling device includes a straight collection pad. The shortened direct sampling device with a housing that mates with the seating portion305to rest the shortened direct sampling device in the minimized developer solution vial300without resting collection pad of the shortened direct sampling device at the bottom of the minimized developer solution vial300. The sidewall portion307is substantially longitudinally straight since the collection pad has a generally rectangular shape. The guiding wall portion311helps to guide the shortened direct sampling device toward the center of the minimized developer vial cavity301.

FIGS.6C and6Dshow exemplary bottom and bottom perspective view illustrations of the minimized developer solution vial for use with an assay device of one embodiment of the invention. The base304of the minimized developer solution vial300helps to keep the minimized developer solution vial300upright while the shortened direct sampling device rests.

FIGS.6E and6Fshow exemplary cross-sectional front and front perspective view illustrations of the minimized developer solution vial ofFIG.6Afor use with an assay device from section F-F of one embodiment of the invention. The guiding wall portion311includes an interior wall to the cavity that includes first section308and second section310. The second section310surrounds a housing of the shortened direct sampling device mated to the seating portion305. The first section308is between opening306and the top of the second section310. As shown, the minimized developer solution vial300does not include an extraction portion and uses only an assay device that may also be used to directly collect a sample from a patient.

FIGS.7A-Dshow exemplary front view illustrations of a swab in use with a developer solution vial ofFIGS.1A-3B, of the invention. The figures show a sampling device401that is a swab entering and interfacing with the developer solution vial100.FIG.7Ashows the sampling device401and developer solution vial100separately.FIGS.7B-7Dshows the sampling device401in the developer solution vial100from various views.FIG.7Cshows a cross-sectional view of the mated sampling device401and developer solution vial100, showing how the sampling device401would be centered and squeeze through the extraction portion into the developer solution vial cavity to elute a sample into the developer solution.

FIG.8A-Dshow exemplary front view illustrations of an assay device with an integrated sampling device in use with a developer solution vial ofFIGS.1A-3B, of the invention. The figures show an assay device501with an integrated sampling device entering and interfacing with the developer solution vial100.FIG.8Ashows the assay device501with an integrated sampling device and developer solution vial100separately.FIGS.8B-8Dshows the assay device501with an integrated sampling device in the developer solution vial100from various views.FIG.8Cshows a cross-sectional view of the mated assay device501with an integrated sampling device and developer solution vial100, showing how the assay device501with an integrated sampling device would be centered and be seated at a seating surface503into the developer solution vial cavity to wick a sample from the developer solution into the assay device501.

FIG.9A-Dshow exemplary front view illustrations of a direct sample collection pad in use with the minimized developer solution vial ofFIGS.6A-6D, of the invention. The figures show a direct sampling and assay device601entering and interfacing with the developer solution vial300.FIG.9Ashows the direct sampling and assay device601and developer solution300separately.FIGS.9B-9Dshows the direct sampling and assay device601in the developer solution vial300from various views.FIG.9Cshows a cross-sectional view of the direct sampling and assay device601and minimized developer solution vial300, showing how the direct sampling and assay device601would be centered placed into the developer solution vial cavity to elute and wick a sample from the developer solution into the direct sampling and assay device601.

Sampling and Testing

In a first embodiment, an assay method comprises the steps of collecting a sample on a sampling device. Inserting the sampling device with the collected sample in a developer solution vial keyed to a sampling device and assay device. Inserting the sampling device submerges the sampling device in developer solution held within a cavity of the developer solution vial to wet the sampling device with the developer solution. The sampling device is then agitated within the developer solution to elute the collected sample from the sampling device and mix the collected sample with the developer solution. Once agitated, the sampling device is removed from the developer solution. When removing the sampling device, an extraction portion of the developer solution vial further recovers some of the remaining developer solution and collected sample from the sampling device. Then an assay device is inserted into the developer solution to run the assay for diagnosis.

In a second embodiment, a second assay method comprises the steps of collecting a sample on a sampling device integrated with an assay device that directly collects samples. The sampling device of the assay device with the collected sample is inserted into a developer solution vial to submerge the sampling device of the assay device in the developer solution within the cavity of the developer solution vial to wet the sampling device with the developer solution and run the assay for the diagnosis.

In one embodiment, a method for using a developer solution vial with an assay device to diagnose a respiratory disease in a patient, of the invention. The method can be broken down into two main steps. The first step is collection, and the second step is testing.

In one embodiment, the collection steps begin with bringing the tests including both the developer solution vial and LFA to an operating temperature of 15°-40° C. (59°-104° F.). Setting up a testing stand for resting the developer solution vial. Another embodiment of the invention is a kit (not shown) where the LFA and developer solution vial come in a dual-chamber pouch which keeps the developer solution vial and LFA sanitary and prevents accidental adulteration of a test. The developer solution vial includes a cap which is gently rocked off the developer solution vial and seals the developer solution in the developer solution vial prior to use. The developer solution vial is placed into the slot in the stand.

The patient may then be instructed to blow their nose into a tissue and then discard. The patient removes the LFA device, such as assay device501above, from the pouch and checks for an absorbent packet which prevents absorption of liquid by the collection pad of an LFA. The collection pad should not be touched. The collection pad from the assay device is pressed firmly into a nostril against the nasal wall and rotated a number of times (15) in each nostril.

The testing steps begin by inserting the assay device into the developer solution vial on the testing stand. SeeFIGS.9A-9C. The assay device may be agitated in the developer solution by swirling the collection pad of the assay device a number of times (10) and then leaving the assay device in the developer solution and returned to the testing stand. In other embodiments, the assay device or sampling device may be spun, tapped, or plunged up and down in the developer solution to elute the sample from the assay device501with the integrated sampling device, and into the developer solution. The user should make sure to leave a results window of the assay device facing the user. The user then leaves the assay device in the developer solution vial while the test is running for between 30 and 40 minutes. In one embodiment, a pink indicator fluid will appear and be wicked to the results window.

In some embodiments, the developer solution vial100may be shipped separate from the developer solution. Thus, the developer solution vial100may require filling. In some embodiments, the developer solution vial100may be made of a translucent, opaque, or transparent material that allows a user to see a mark for a fill-line and/or the amount of developer solution that has been added to the developer solution vial100.

In some embodiments, the developer solution vial100uses an assay device that is configured to allow direct sample collection with an assay device501with an integrated sampling device. In such a case, agitation may not be necessary to elute the sample from the collection pad. Rather, simply inserting the assay device into the developer solution vial100may wick the sample directly into the through the assay strip of the assay device.

In some embodiments, a method includes at least the steps of collecting a sample with a sampling device; inserting the sampling device with the collected sample into a developer solution vial to a sufficient depth in a developer solution within the cavity to wet the sampling device with the developer solution; agitating the sampling device at a sufficient depth within the developer solution to elute the collected sample from the sampling device and mix the sample with the solution; withdrawing the sampling device from the developer solution vial such that the extraction portion of the developer solution vial to force a substantial portion of any sample or developer solution from the sampling device and into the cavity; and inserting a lateral flow assay device into the developer solution vial in the developer solution containing the sample to run the assay for diagnosis. In some embodiments, the sampling device may be wet with developer solution before collection of the sample from the patient.

Collecting the sample with a sampling device includes collection by a swab or applicator, or an assay device integrated with a sampling device, such as a collection pad that is capable of directly collecting samples. The sample may be collected from a patient or surface by pressing, swabbing, wiping, or dabbing at a bodily fluid of the patient or the surface. The collecting may require the user to wipe the surface or bodily fluid a number of times to better ensure collection of enough sample for the assay device to run the diagnostics. For example, wiping at the anterior nares five times to ensure good coverage by the sampling device.

The sampling device is then inserted into a developer solution vial100to submerge the sampling device in the developer solution within the cavity of the container to wet the sampling device with the solution and remove then remove the sample from the sampling device by elution. The elution may be through any number of methods from agitating the sampling device in the developer solution to pressing the sampling device against the extraction portion103to forcefully remove the sample from the sampling device. Agitating the sampling device at a depth within the developer solution to submerge the head of the sampling device and elute the collected sample from the sampling device and mix the sample with the developer solution may include swirling, rotating, shaking, tapping, push-pull motion, etc. The agitation should limit or prevent spillage of developer solution.

Once eluted, withdrawing the sampling device from the developer solution vial such that the extraction portion of the developer solution vial forces a substantial portion of any sample or developer solution from the sampling device and into the cavity. Then, inserting the assay device into the developer solution vial in the developer solution containing the sample to run the assay for diagnosis. The assay device may include any fluid flow assay devices, however is preferably a lateral flow assay device.

In the case of an assay device integrated with a sampling device, such as a collection pad that is configured to directly collect samples, the assay device collects the sample at the sampling device of the assay device. The sampling device is then inserted into the developer solution vial cavity with the developer solution to wet the sampling device and wick the sample into the rest of the assay device. The sample moves through the assay strip of the assay device and eventually displays the results for diagnosis.

Although the invention has been described with reference to various exemplary embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the invention. Those having skill in the art would recognize that various modifications to the exemplary embodiments may be made, without departing from the scope of the invention. Various features and/or characteristics of differing embodiments of the invention may be combined with one another. Any directional aspects of an enclosure device of the invention as it is described, oriented or appears in the drawings are presented for convenience only; they are not intended to be limiting or to imply that the device has to be used or positioned in any particular orientation.