WO2002065105A1

WO2002065105A1 - Swabbing and assaying structures

Info

Publication number: WO2002065105A1
Application number: PCT/US2001/004305
Authority: WO
Inventors: Lawrence Silver; Michael Juliano
Original assignee: International Food Protection
Priority date: 2001-02-12
Filing date: 2001-02-12
Publication date: 2002-08-22

Abstract

Swabbing and assaying structures, and selected methods of use, enable a test surface to be swabbed, and subsequently assayed, providing a quantitative determination of the quantities of analyte collected from the test surface. The swabbing and assaying structures include a pre-wetted swabbing pad having (54) a first surface (54a) for contacting and suitably swabbing the test surface to collect the analyte. Dried reagents that are impregnated within or upon a porous pad (68) are then brought into pressure contact with the swabbing pad, within a light-tight environment (180). If sufficient analyte was collected by the swabbing of the test surface, an assaying reaction will commence that produces detectable and quantifiable low level luminescent emissions.

Description

TITLE : Swabbing and Assaying Structures

Cross Reference To Related Applications

The subject matter provided herein is related to U.S.

Application Serial No. 09/228330 filed on Jan 11, 1999, which now stands allowed, and further to U.S. Application Serial No. 09/370306 filed on August 9, 1999 and U.S.

Application Serial No. 09/510954 filed on Feb 22, 2000.

Technical Field The present invention relates generally to swabbing and related structures, and methods that are useful for assaying purposes. More particularly, the invention relates swabbing and related structures for collecting analyte from a test surface and conducting a self-contained assay in a light-tight environment to efficiently detect and quantify low level luminescent emissions, which are substantially proportional in intensity to the volume of analyte collected from the test surface . Background Art

A number of techniques and arrangements have been proposed that employ ' luciferase-luciferin reactions' to assay and quantify a volume of analyte. As is well known, luciferase- luciferin reactions involve the measurement of adenosine triphosphate (ATP) , a material central to metabolism in virtually all living cells. Since ATP is necessary for all living organisms to function, it serves as an excellent marker to indicate the presence of living matter (e.g., bacterial and or other microbial matter) . Accordingly, if one can ascertain (with a reasonable accuracy) a quantity of ATP present in a sample or specimen, either through direct or indirect measurement, one may make a determination of the quantity of microbes, microbial matter, or more generally the amount of 'analyte' present. A most preferred indirect method of measuring and quantifying a volume of analyte is by determining the levels of ATP present by employing a luciferase-luciferin assaying reaction. A properly conducted luciferase-luciferin reaction will produce detectable and measurable levels of luminescent emissions - even with relatively small quantities of analyte (e.g., down to 1 femtomole, or so) . However, it must be understood that the level of luminescent emissions generated by such assaying reactions may be quite low. For example, such intensity levels of emissions may be as low as a fraction of a pico-watt. The measurement of emission levels this low necessitates sensitive, efficient, and accurate detecting and measuring systems that include low noise and often specialized components .

Assaying arrangements that employ bioluminescent (ATP) assaying reactions to produce low levels of luminescent emissions also require a means to collect a specimen or sample. Often, a simple and common foam or cotton swab is utilized. Once a sample of analyte has been collected upon the swab, the sample is exposed to suitable enzymes and reagents to cause the luminescent emissions-producing reaction to occur. Such a reaction may be termed an assaying reaction. As such, the prior art generally provides for the assaying activities to commence, and subsequently, the sample with the assaying reaction in progress, to be placed into a measurement chamber for sensing and quantification. There are many examples of swabbing arrangements and suitable luminometer apparatus that are employable collecting an assay sample, starting an assay via the addition of suitable chemicals, and quantifying the assaying reaction in progress. For example, as can be seen in U.S. Patent 5,833,923 to McClintock discloses a sampling device including a sampling portion, a reading portion, and an elongated transfer portion. The sampling device of McClintock calls for the target sample to be collected upon the sampling portion, at least one carrier liquid to be introduced, which causes the transport of a portion of the sample collected to the reading portion having situated thereat chemiluminescent reaction components', required to cause the assaying reaction to commence. Next, the sampling device is inserted into a quantifier for observation and quantification. As such, the McClintock device does not contain all the items necessary for collecting analyte, sealing the collected analyte in a light tight environment, and subsequently enabling the commencing and sensing of an luminescent assaying reaction. Also, the McClintock sampling device, and other sampling devices known in the art, do not provide sample (analyte) collection and efficient assaying to occur without loosing, diluting, and or moving a portion of a collected sample to a location wherein suitable chemicals and reagents are provided to commence the assaying reaction. Accordingly, known prior art devices do not provide for swabbing structures and associated assaying arrangements having simple, self-contained, and efficient structures to enable the collecting of a sample of analyte, initiate an assaying reaction in a light-tight environment, and subsequently sense and quantify low levels of luminescent emissions produced by the reaction. Importantly, such systems have not been especially usable in the field, for example, if a cleanliness or hygiene inspection is being conducted in a hospital operating room or in a restaurant's kitchen. Therefore, skilled persons will recognize the need for improved low level, self-contained and highly portable assaying apparatus, and associated efficient swabbing arrangements and structures . A most preferred swabbing structure would enable specimens to be collected, provide for the establishing of a suitable light-tight assaying environment or enclosure, include required chemical and biological materials to initiate the assaying reaction (once the light-tight environment has been established) , and further enable or support the efficient quantifying of the low level luminescent emissions produced by an assaying reaction. If properly quantified, the actual or relative intensity levels of the low-level luminescent emissions may be employed to determine a measure of the volume of microbial matter that was collected by the swabbing of a test surface. A full understanding of the present invention, including an understanding of a number of capabilities, characteristics, and associated novel features, will result from a careful review of the description and figures of the embodiments provided herein. Attention is called to the fact, however, that the drawings and descriptions are illustrative only. Variations and alternate embodiments are contemplated as being part of the invention, limited only by the scope of the appended claims. Summary Of The Invention

In accordance with the present invention, swabbing structures and methods of use, are provided for collecting a volume of analyte from a test surface and supporting a quantitative determination of the relative volume collected. A detector cap assembly providing an internal light-tight environment for conducting a self-contained assay of analyte collected from a test surface includes a first portion and a second portion. The first portion is structured with a first porous pad coupled thereto. The first portion is removably fixable to a detector head assembly of a luminometer to enable the efficient detecting and quantifying of low level luminescent emissions emitted, at least in part, from the first porous pad. The second portion is structured with a second porous pad suitably coupled thereto. The second portion is specifically configured to be removably fixable to the first portion to establish the light-tight environment. The light-tight environment is structured to house the first porous pad and the second porous pad, and possibly other porous pads and related items, to enable the commencing and detecting of low level luminescent emissions free of any incident ambient light reaching either of the first and second porous pads. Importantly, the first portion and the second portion are structured to enable a user to bring the first porous pad (coupled to the first portion) into pressure contact with the second porous pad (coupled to the second portion) within the light-tight environment. The pressure contacting possibly causing an assay reaction producing low level luminescent emissions that may be detectable and quantifiable by a suitable, preferably hand-holdable and self- contained luminometer. Such a luminometer is provided by U.S. Patent application No. 09/228,330 (also available as PCT publication WO 00/42419) .

A detector cap assembly in accordance with the present invention may be embodied with the first porous pad of the first portion provided as a swabbing pad, or alternately a dried reagent impregnated or holding porous pad. If the first portion is provided with a pre-wetted swabbing pad (arranged to swab the test surface when separated from the second portion) , and possibly other porous pads superposed by the swabbing pad, then preferred embodiments of the invention would be provided with a second portion having coupled thereto a second porous pad provided as a dried reagent holding porous pad. Similarly, if the first portion were provided with a dried reagent holding porous pad, and possibly other porous pads superposed by the dried reagent holding porous pad, then the structure of the invention must include a second portion having coupled thereto a second porous pad provided as a pre- wetted swabbing pad. Accordingly, the second porous pad would be provided to compliment the first porous pad in preferred embodiments of the invention. The invention further discloses preferred methods for swabbing a test surface in order to collect analyte and subsequently quantitatively indicate the presence and volume of analyte collected upon the swabbing surface. The methods commence with the swabbing of the test surface with a pre- wetted swabbing pad. A first surface of the swabbing pad is suitably shaped and configured for contacting the test surface to collect available analyte. Next, the first surface of the swabbing pad is brought into pressure contact with suitable dried reagents, most preferably of another porous pad, in a light-tight environment. The light-tight environment is most preferably provided in substantial part by portions of the first portion and second portion of the detector cap assembly. The pressure contacting of the first porous pad with the second porous pad possibly causing a detectable low level luminescent reaction, if sufficient analyte has been collected.

Brief Description Of The Drawings

In the drawings, like elements are assigned like reference numerals. The drawings are not necessarily to scale, with the emphasis instead placed upon the principles of the present invention. Additionally, each of the embodiments depicted are but one of a number of possible arrangements utilizing the fundamental concepts of the invention. The drawings are briefly described as follows:

Fig. 1 illustrates a perspective view of an embodiment of a detector cap assembly and a detector head assembly of a suitable luminometer in accordance with the present invention.

Fig. 2 provides a perspective view of the detector cap assembly of Fig. 1 with a first portion installed over the detector head assembly of a luminometer, and ready to be used for swabbing and analyte collection.

Fig. 3 depicts the detector cap assembly of Figs. 1 and 2, reassembled, housing a first and a second porous pad and related structures in an interior, darkened, light-tight environment . Figs. 4A and 4B provide sectional side views of a first embodiment of a detector cap assembly of the present invention taken along the lines 4A-4A of Fig.l and the lines 4B-4B of Fig. 3, respectively.

Fig. 5 illustrates another embodiment of a detector cap assembly and a detector head assembly of a suitable luminometer. Fig. 6A shows the detector cap assembly of Fig. 5 installed upon (or removably fixed to) the detector head assembly of Fig. 5.

Fig. 6B depicts the detector cap assembly of Figs. 5 and 6A with a second portion and a spacer shown separated from a first portion thereof.

Figs. 7A and 7B provide sectional side views of an embodiment of the detector cap assembly and a detector head assembly, taken along the lines 7A-7A and 7B-7B of Fig. 5, which are consistent with the embodiment of Figs. 5, 6A and 6B.

Fig. 7C provides sectional side view of the detector cap assembly of Fig. 7A mated to the detector head assembly of Fig. 7B, after a spacer portion has been removed. Fig. 8 provides a sectional side view of yet another possible embodiment of a detector cap assembly.

Fig. 9 depicts an arrangement of important elements of a most preferred embodiment of an analyte collection and assaying means in accordance with the invention. Fig. 10 illustrates an alternate embodiment of the analyte collection and assaying means of Fig. 9. Partial List Of Reference Numerals

12 - detector head assembly

14 - transparent or optical window

20a, 20b - detector head housing

30 - detector cap assembly

32 - first portion (of detector cap assembly 30)

34 - wall structure of first portion

34a - first opening of first portion

34b - second opening of first portion

36 - internal cavity of first portion

40 - second portion (of detector cap assembly 30)

42 - wall structure of second portion

42a - first end of second portion

42b - second end of second portion

46 - outer surface of wall structure 42 '

46a - threaded portion of outer surface

48 - internal chamber of second portion

52 - opening to internal chamber of the second portion

54 - swabbing pad

54a - first (swabbing) surface (of swabbing pad 54)

54b - second surface (of swabbing pad 54)

56 - support and reading pad

56a - first surface (of reading pad 56)

56b - second surface (of reading pad 56)

64 - movable structure

64a - surface of movable structure

68 - porous pad

70 - moisture barrier, or sealing means

70a - support ring for first barrier

78, 78a - second barrier

79 - (small) pocket

80 - cap-like portion

82 - wall structure of cap-like portion

82a - first (open) end of cap-like portion

82b - second (closed) end of cap-like portion

84 - top surface of cap-like portion

86 - interior surface of wall structure

86a - threaded portion of interior surface

120 - electronic shutter

124 - photodetector or semiconductor photodiode

124a - second semiconductor photodiode (if included)

130 - detector cap assembly (an alternate embodiment)

132 - first portion (of alternate embodiment)

134 - wall structure of 132

140 - second portion ( of alternate embodiment)

142 - wall structure (of second portion)

144 - internal cavity of 140

160 - spacer

180 - light-tight environment Detailed Description Of Embodiments Of The Invention

It is important to establish the definition of a number of terms and expressions that will be used throughout this disclosure. The term 'luminometer' defines a means to measure low levels of luminescent emissions. Importantly, a preferred luminometer for use with the present invention is embodied to provide a very portable, hand holdable or belt/waist supported, self-contained instrument. Such an instrument could be used 'on-site' to measure low level luminescent emissions produced when an assay is being conducted. In addition, a most preferred luminometer would be structured with a detector head assembly, as fully described hereinafter. The expression ^x low level luminescent emissions', and similar expressions, are to be assumed to indicate levels of emissions typified by, for example, a luciferase-luciferin type of bioluminescent assaying reaction. Such an assaying reaction, as well as other known reactions, may produce a correspondingly low level emission, say for example, as low as one-hundredth of a pico- watt. Further, such emissions may preferably be within the visible light spectrum. The term 'analyte' is to be understood to encompass small microbes including, but not limited to, bacteria, viruses, other chemical moieties, and the like. Further, 'analyte' may be assumed to be singular or plural, as appropriate for the context in which it is used. The term 'wall structure¹ will be used primarily to refer to side walls of several portions of a detector cap assembly, and equivalents thereof, of the present invention. It should be understood, however, that the term wall structure may be extended to include a top or end wall of a respective item being described, as determined by the context in which the term (wall structure) is applied. In addition, preferred wall structures will be opaque. Two other very important terms, which will also be used extensively in this disclosure, are 'first portion' and 'second portion'. The term first portion may be assumed to indicate a portion of a detector cap assembly of the invention, or an equivalent structure, which is closest to, and preferably removably fixable to the detector head assembly of a suitable luminometer. Similarly, the second portion may be assumed to indicate another portion of the detector cap assembly that is structured to mate to, and/or be removably fixable to, the first portion so as to, among other things, complete an interior chamber or cavity that houses porous pads of the present invention in a darkened, light-tight environment. The expression 'light-tight environment', and similarly 'light-tight manner', and equivalents, are intended to indicate that the structures of a first portion and a second portion will mate (i.e. be removably fixable to each other) such that ambient light is shielded or blocked so that only luminescent emissions emitted from one or more porous pads, and possibly other associated internal structures, are directly incident upon, a photo- detection means provided by the luminometer. The terms 'coupled', 'coupled to', etc., are to be understood to mean that two items are either directly contacting and fixed to one another, or alternately said items are fixed to each other via one or more additional (implied) structures or components. Other important terms and definitions will be provided, as they are needed, to properly and fully define the present invention and its associated novel characteristics and features .

Referring now to Fig. 1, there is illustrated therein an embodiment of a detector cap assembly 30, along with a preferred embodiment of a detector head assembly 12. The detector head assembly 12, which represents a portion of a preferably hand-holdable self-contained luminometer, may include a transparent window 14, or an equivalent structure. As illustrated, the transparent window 14 forms a portion of a detector head housing 20a of a housing of the luminometer to enable the detection of the luminescent emissions entering the luminometer by way of the transparent window 14. Most preferably, and as illustrated in Figs. 4A, 4B, 7B, etc., a semiconductor photo detector 124, which may be termed a

'photo-detection means', is located immediately behind the transparent window 14 so that low level emissions detected thereby are detected in an 'efficient' fashion. Indeed, as skilled persons will appreciate, this arrangement may yield a possibly most efficient arrangement of components, as will be discussed in detail below. Importantly, the transparent window 14 provides a portal through which low level luminescent emissions may immediately pass to be efficiently detected and quantified. Quantified (i.e., measured) luminescent emissions would be indicative of the relative volume of analyte being assayed in accordance with the invention. It should be noted that the detector head assembly 12 may be housed within a detector head housing 20a portion of a suitable housing. However, many suitable arrangements may be provided to house the detector head assembly 12 of the present invention. For example, another preferred and equivalent structural arrangement may be provided having the transparent window 14 and the photo-detection means recessed within a housing 20b, which will be fully discussed when referring to Figs. 5 through 7C. As such, a detector head assembly 12 of Figs. 1 through 4B, which is illustrated as a male-type structure, may be converted to an equivalent arrangement possibly having a 'detector receptacle' or 'detector well¹, which may be configured to provide a female-type of structure. However, it must be noted that the term 'detector head assembly' is to be broadly defined to include protruding, surface type, or more recessed assemblies and structures having a suitable photo detecting element situated adjacent and proximate to the source of luminescent emissions to enable the efficient detecting of said emissions.

Turning again to Fig. 1, there is depicted therein an embodiment of a detector cap assembly 30 of the present invention. The detector cap assembly 30 is comprised of a first portion 32 and a second portion 40. The first portion 32 is configured having a wall structure 34 forming, at least in part, an internal cavity 36. As implied in Figs. 1 and 2, and explicitly shown Fig. 4A, the wall structure 34 of the first portion 32, which may be provided with a substantially cylindrical form (as illustrated) , or other suitable shapes, defines a first opening 34a and a second opening 34b. In order to restrict ambient light from being incident upon porous pads of the invention (including the swabbing pad 54) during assaying activities, the wall structures of the first portion 32 and second portion 40, as well as portions of a housing of the luminometer and possibly other structures, must be opaque and suitably structured to provide the required light-tight environment.

The first opening 34a and wall structure 34 of the first portion 32 are structured to enable the first portion 32 to be removably fixable to the detector head assembly 12 in a light- tight manner (see Figs. 3 and 4B) . As discussed above, the expression 'light-tight manner' is intended to indicate that the first portion 32 will mate to, and be removably fixable to, the detector head assembly 12 so as to only enable luminescent emissions passing through the second opening 34b (Fig. 4A) of the first portion 32 to be incident upon the photo-detection means situated behind the transparent window 14. In a first preferred embodiment, the first portion 32 will removably install upon the detector head assembly 12 such that at least a portion of the detector head assembly substantially fills the cavity 36 of the first portion 32. This arrangement will position the transparent window 14 of the detector head assembly 12 (as clearly shown in Fig. 4B) in close proximity to the second opening 34b of the first portion 32. Accordingly, this structure will minimize the distance between the photo-detection means 124 and one or more included porous pads, to enable the 'efficient detecting' of the low level luminescent emissions emitted, at least in part, from the porous pads. This arrangement, wherein said distance is minimized, enables the low level luminescent emissions in accordance with the present invention to be readily and efficiently detected when produced or generated by an assaying reaction that is occurring on, within, or adjacent to one or more included porous pads .

Referring again to Fig. 1, it may be assumed that the detector cap assembly 30 may have been removed from a sealed, possible sterile, packaging arrangement (not explicitly shown) . Once removed from the packaging arrangement, the detector cap assembly 30 may be installed upon a suitable detector head assembly in the light-tight manner (as illustrated if Fig. 3). Next, as shown in Fig. 2, the second portion 40 is separated from the first portion 32. A first porous pad, which when considering the embodiments of Figs. 1 through 4b will be designated 'swabbing pad 54', is now exposed and available for swabbing of a selected test surface to collect analyte (to be assayed) upon the first surface 54a. As illustrated, swabbing pad 54 is coupled to the first portion 32 of the detector cap assembly 30 and arranged to substantially cover the second opening 34b thereof. When considering the embodiments of the swabbing pad 54 of the invention, such pads may be provided as a substantially flattened, pre-wetted "bibulous" and porous material, as depicted in Fig. 2. It must however be noted that the swabbing pad 54 may also be provided in a large variety of alternate shapes, as can be seen in Figs. 2, 4A, 7A, etc. As shown therein, a first surface 54a of the depicted (porous) swabbing pads 54 may not be flat. Indeed, when it is desired to swab and collect analyte from a crevice or along a curved, angled, or folded surface, the swabbing pad 54 may be most preferably structured having a shape similar to that illustrated in Figs. 4A or 9. Importantly, as shown, the swabbing pad 54 is most preferably structured with a substantially flattened second surface 54b, which is ideally positioned superposed over and essentially abutting the window 14 of the detector head assembly 12 (when the first portion 32 is removably fixable over the detector head assembly 12 in the light-tight manner) . This arrangement and structure, as discussed above, provides an efficient detecting mechanism in accordance with the present invention by minimizing a distance between a photo detection means and a source to the low level luminescent emissions .

After one or more selected test surfaces have been swabbed to collect analyte, the second portion 40 is re-installed over the first portion 32, as depicted in Fig. 3. Since the porous swabbing pad 54 is now covered by the second portion 40 establishing a light-tight environment, ambient light is no longer incident upon swabbing pad 54 (as well as other pads and items now contained in the light-tight environment) .

Turning again to Figs. 4A and 4B, there are illustrated therein sectional views that are consistent with the embodiment illustrated in Figs. 1, 2 and 3, and as such are representative of one possible internal structure that may be provided for this embodiment. As depicted, the second portion 40 is configured to house a movable structure 64 within a chamber 48, as best seen in Fig. 4A. The movable structure 64 of this embodiment may be embodied having a substantially curved or concaved surface 64a, as illustrated, that is oriented facing and proximate to, yet retracted from, the first surface 54a of the swabbing pad 54. The movable structure 64 is also configured to be movable between a first retracted position, wherein the movable structure 64 is contained within the chamber 48 (as illustrated in Fig. 4A) , and a second deployed position (as illustrated in Fig. 4b) . A porous pad 68, which may be termed 'a second porous pad' of the present embodiment, is fixable to and preferably arranged to substantially cover a surface 64a of the movable structure 64. As such, the porous pad 68 may be said to be 'fixed to the second portion', 'fixable to the second portion', or alternately, 'coupled to the second portion', as illustrated.

In the embodiments of the detector cap assembly 30 shown in Figs. 1 through 4B, the porous pad 68 is preferably impregnated with suitable dried reagents that are activated by wetting when brought into pressure contact with a first porous pad, such as a pre-wetted swabbing pad 54. It should be noted that the terms 'pressure contact' and 'pressure contacting' may be assumed to indicate that a porous pad (e.g., second porous pad 68) is brought into contact with another porous pad (e.g., first porous swabbing pad 54) with a sufficient pressure to enable the wetness of the swabbing pad 54 to wet and activate dried reagents that impregnate the porous pad 68. Skilled individuals will understand that the reagents will then dissolve and be drawn, at least in part) from the porous pad 68 to the swabbing pad 54. In a possibly most preferred embodiment of the invention of Figs. 1 through 4B, when sufficient amounts of analyte (say a volume in the range of 10 to 100 microliters) are collected upon the swabbing pad 54, and sufficient luciferase-luciferin dried reagents are impregnated within the porous pad 68, a detectable luciferase- luciferin reaction will occur. This reaction, which may be termed an 'assaying reaction' having associated therewith assaying activities, may be assumed to produce low level luminescent emissions. It should be noted that the expression "possibly resulting in an assaying reaction producing detectable low level luminescent emissions" is intended to indicate that an assaying reaction will occur at a sufficient intensity, if analyte is present in a sufficient volume on one or more porous pads of the invention. Conversely, if a sufficient volume of analyte is not present, the assaying reaction will not provide emissions with a sufficient intensity to be detected, properly measured, and or quantified. In this latter case, it may be assumed that the test surface that was swabbed was relatively free of analyte being tested or checked for.

It may further be noted that although the porous pad 68 and the swabbing pad 54 are illustrated as being a single monolithic section of material, it is contemplated that each may actually be provided as multi-layer structures. For example, the porous pad 68 may include multiple layers with individual layers containing respective reagents, buffering agents, etc. This aspect of the invention will be further addressed when referring to Figs. 9 and 10.

To assure a clear understanding of the description of the present invention provided herein, it is helpful to establish a relationship of the first portion 32 and the first porous pad, with the second portion 40 and the second porous pad. The first portion 32 will be defined as the portion that is coupleable or fixable directly to the detector head housing 12 or 12a. Further, the first porous pad, which may be either a swabbing pad 54 or a porous pad 68, is fixed or coupled to the first portion 32. Similarly, the second portion 40 is structured to be mated to the first portion 32 to complete the light-tight environment, and further has fixed or coupled thereto a second porous pad. Again, the second porous pad may be either a porous pad 68 or a swabbing pad 54, which ever is needed to mate to and complement the first porous pad.

In accordance with the present invention, a preferred method of examining a test surface is realized by swabbing the surface in order to collect and subsequently quantitatively indicate the presence of analyte swabbed off of the test surface. To this end, the methods of the invention may be realized with the exemplary structures and arrangements provided herein, as well as other structures providable by skilled individuals who have carefully reviewed the content of this disclosure. The methods of the present invention may involve several preliminary steps, such as installing the detector cap assembly 30 upon the detector head assembly 12, calibrating the luminometer, as well as other possible initial steps. Next, as shown in Fig. 2, a first porous pad, such as swabbing pad 54, is exposed. A user may then swab one or more selected test surfaces by contacting the first surface 54a of a pre-wetted swabbing pad 54. As discussed, the (porous) swabbing pad 54 may be structured with the first surface 54a shaped and configured for contacting the test surface to collect portions of available analyte situated there on.

After one or more test surfaces have been swabbed in an attempt to collect analyte upon the first surface 54a of the swabbing pad 54, the light-tight environment is re-established when the second portion 40 of the detector cap assembly 30 is re-installed over the first portion 32. At that point both the first porous pad and the second porous pad are shielded from ambient/external lighting sources, as depicted in Fig. 3 and 4B. Next, or possibly in the process of replacing the second portion 40, the first surface 54a of the pre-wetted swabbing pad 54 is placed or brought into pressure contact with the reagent impregnated porous pad 68. In a preferred embodiment, the pressure contacting is realized, for example, by moving a movable portion 68 from a first retracted position (as depicted in Fig. 4A) to a second deployed position (as depicted in Fig. 4B) . This may be accomplished with the illustrated structure, or any other arrangement that enables the desired pressure contacting to occur after swabbing and establishing the light-tight environment. For example, a very simple structure is provided by the embodiment Figs. 5 through 7C, which may be readily adapted to the embodiment depicted in Figs. 1 through 4B.

In preferred embodiments of the invention, when the first porous pad is brought into pressure contact with a suitably shaped second porous pad, the first surface 54a of a swabbing pad 54 and the second surface 54b thereof are compressed with the distance between at least one portion of the first surface 54a and the second surface 54b being substantially reduced with said pressure contacting. This will clearly result in a better wetting of the porous pad 68. In addition, such a compression of the swabbing pad 54 may importantly provide for an even more efficient detecting of any emitted low level luminescent emissions, with the detecting realized by a detection means that is efficiently (e.g., closely) positioned proximate to the second surface 54b of the first porous pad. It may be noted that the term 'sufficiently reduced', as applied above to the compression of the swabbing pad and or porous pad, may be assumed to indicate that the distance between at least a portion of the first surface 54a and the second surface 54b of the swabbing pad 54 is reduced by at least 15% to 70% of the uncompressed distance therebetween.

An important characteristic of preferred embodiments of the present invention is the use of a swabbing structure wherein swabbing and collecting of analyte occurs on a first side or surface (e.g., first surface 54a of the swabbing pad 54) , with detectable low level luminescent emissions emitted from a second side or surface (e.g., second surface 54b). The emitted luminescent emissions may then be coupled to, and efficiently detected by a suitable photo-detecting means. As can be seen in Fig. 4B, the pressure contacting of the swabbing pad 54 and the porous pad 68 occurs within close proximity of a photodiode 124 - providing for a truly efficient detection arrangement in accordance with the present invention by minimizing the distance between the location of a reaction and the photo-detecting means.

It is also important to note that items such as the first porous pad and the second porous pad, as well as others porous pads and related structures, may most preferably be formed of a material having bright, reflective color, and a porosity or "openness" of, for example, 60% to 95%. Accordingly, porous polymer pads and more generally porous polymeric materials, would provide an example of a most preferred material having a bright reflective coloring and a sufficient openness suitable for use with the present invention. The use of bright and open materials is helpful for several reasons. First, the openness enables a pre-wetted porous pad, such as swabbing pad 54, to absorb and retain a sufficient volume of wetting agent utilized for both swabbing and pressure contacting purposes. In addition, an assaying reaction producing low level luminescent emissions may be easily supported thereupon. A most interesting consequence of the use of porous pads having the above characteristics is that any assaying reaction produced thereupon, results in luminescent emissions being reflected, channeled, and therefore transmitted to other portions or areas of the included porous pad(s) . As such, it may be said that a reflective coloring and open/porous structure of these items 'enhances' the ability to detect and quantify the luminescent emissions produced by a reaction occurring thereupon or therein.

It may also be assumed that emitted photons of the luminescent emissions, which are produced by the assaying reaction, may reach a sensing portion of the photodiode 124 by at least one or more of the following mechanisms: (1) directly from the swabbing pad 54, or another pad superposed over the window 14, (2) indirectly via reflected luminescent emissions (say produced on or near the porous pad 68), and (3) emissions produced by a liquid phase or layer. For completeness, each type of emission delivery mechanism will be briefly discussed. It should be noted that the definitions and descriptions of these terms may be extended and or applied to other, possibly substantially different structures. Direct emissions are emissions associated with a portion of an assaying reaction that is occurring quite close to, if not upon, a second surface of a first porous pad closest to a photo-detecting means. Indirect (reflected) emissions are luminescent emissions that are produced in more distant portions of the assaying reaction. For example, a portion of the reaction occurring near or on the second porous pad. These more distantly produced emissions are reflected and transmitted via a reflective coloration, and the openness of the employed porous pads of the invention. A term that may be used to describe the inherent mechanism (of the employed porous pads) to deliver indirect emissions to a detection means is 'reflective porosity¹. Finally, liquid phase emissions are emissions that may occur or are caused to occur in a layer of liquid situated between a second surface (e.g. 54b of the swabbing pad 54) of a porous pad and an included moisture barrier 78 or 78a. This liquid may preferably be composed of, or include, wetting agent, analyte, and reagents. As shown in Fig. 9, liquid phase emissions may be encouraged by providing a small pocket 79 between an adjacent porous pad 56 and a second (moisture) barrier 78a. It is the above emission delivery mechanisms, and equivalents, in combination with the swabbing structures of the present invention, that provide the unexpected result of being able to accurately detect and quantify low level luminescent emissions of an assaying reaction using means based on inexpensive semiconductor photodiode detectors (as opposed to more sensitive and costly PMT based luminometer devices) .

Skilled individuals will appreciate the need to prevent moisture and humidity from prematurely activating the dried reagents of a reagent impregnated porous pad, such as porous pad 68 of Fig. 4A. If the detector cap assembly 30 (including the porous pad 68) is packaged in a suitable packaging arrangement, then moisture and humidity may be blocked by such a packaging. Alternately, a means may be provided to seal the internal chamber 48 until such a time that the movable structure 64 is to be moved from the first retracted position (Fig. 4A) to the second deployed position (Fig. 4B) . Also, a sealing means must be arranged to enable the suitable wetting of the porous pad 68 when the pressure contacting of the swabbing pad 54 and porous pad 68 occurs. Such a sealing or barrier means may be provided by a first moisture barrier 70, which may be structured to be thin and frangible. The moisture barrier 70 is arranged to cover the opening 52 (Fig. 2) of the second portion 40, preferably in a recessed fashion, as illustrated is Fig. 4A. A support ring 70a may further be provided to support a frangible embodiment of moisture barrier 70, as illustrated. The arranging of the moisture barrier 70 in the recessed fashion enables a portion of an internal chamber 48 having the porous pad 68 and the movable structure 64 contained therein to be hermetically sealed while the movable structure 64 is in the first (retracted) position. As such, the hermetically sealed portion of the internal chamber 48 enables the porous pad 68 to remain completely dry as long as the movable structure 64 is maintained in the first retracted position. The recessed positioning the moisture barrier 70 will also enable the detector head assembly and the first portion 32 to be placed (coextensively) into the second portion 40 without rupturing the moisture barrier 70. Accordingly, after swabbing has been completed, possibly causing analyte to be collected upon the swabbing pad 54, the second portion 40 may be re-installed over the first portion 32 - establishing the required light-tight environment. The movable structure 64, including the porous pad 68, may next be moved from the first retracted position of Fig. 4A to the second deployed position of Fig. 4B, causing the moisture barrier 70 to be ruptured, and pressure contacting realized.

It should be noted that frangible embodiments of the moisture barrier 70 must be structured to be appropriately ruptured when the movable structure 64 is moved from the first retracted position to the second deployed position. The term 'appropriately rupturing¹ (and equivalents) may be defined as rupturing in a suitable fashion so as to enable sufficient wetting agents of the swabbing pad 54 to wet the dried reagents of the porous pad 68 and cause a desired assaying reaction when sufficient analyte is present. As such, a suitable moisture barrier 70 may be scored with score lines (not shown) that are provided to establish rupture or tear locations to facilitate the appropriate rupturing of the moisture barrier 70. Further, if the moisture barrier 70 is provided by a stretched, possibly elastic material, the rupturing may result in a maximal direct contacting of the swabbing pad 54 and the porous pad 68 when the pressure contacting is established.

As illustrated in Fig. 4A and 4B, a transparent supporting and fluid impervious second barrier 78 may be provided under the first porous pad (i.e., swabbing pad 54) and over the second opening 34b of the first portion 32. The second barrier 78 may be included to firmly seal the second opening 34b to prevent the transport of items such as moisture, analyte, reagents, contaminants, etc., therethrough. As skilled persons would appreciate, the inclusion of the moisture barrier 78 prevents any contaminants, analyte, and or other matter from passing from the swabbing pad 54 to the detector head assembly 12 or visa-versa.

Primary purposes for employing a volume of wetting agent is to enable analyte to be easily collected, while also providing a means to wet and activate the dried reagents of the porous pad 68. When considering appropriate wetting agents to employ, a volume of sterile water, a nucleotide releasing reagent, and or a variety of other known buffering agents may be used. The particular wetting agent may actually be determined by skilled persons as a function of the particular analyte to be detected or assayed, as well as the particular dried reagents employed with the porous pad 68.

As shown in Figs. 4A and 4B, the depicted embodiment of the detector cap assembly 30 is arranged with the second portion 40 comprising an outer cap-like portion 80 having a preferably cylindrical wall structure 82 that is closed by a top surface 84 at a second end 82b. The first end 82a of the wall structure 82 of the cap-like portion 80 is open. The wall structure 82 is arranged with a threaded portion 86a that is provided on an interior surface 86 thereof. As shown in Fig. 4A and 4B, the threaded portion 86a of the interior surface 86 may most preferably begin proximate to the second or closed end 82b and extend a suitable distance (e.g., approximately halfway or so) down the height of the cap-like portion 80 along the interior surface 86. As shown, the second portion 40 of the embodiment of Figs . 4A and 4B is further arranged having a wall structure 42 , and a first end 42a and a second end 42b. An outer surface 46 of the wall structure 42 of the second portion 40 is configured with a treaded portion 46a that is structured to mate to and engage the threaded portion 86a of the interior surface 86 of the outer cap-like portion 80. The respective engaged threaded portions thereby enabling the outer cap-like portion 80 to move along a common center or longitudinal axis of the second portion 40 (and the outer caplike portion 80) when the outer cap-like portion 80 is rotated about the center axis with respect to the second portion 40. This rotation effectively causes the outer cap-like portion 80 to be screwed coaxially and at least partially coextensively down and over the second portion 40, moving the movable portion 64 (or an equivalent structure supporting the porous pad 68) from the retracted position to the deployed position. As is shown in Figs. 4A and 4B, the movable structure 64 may be fixed directly to the top surface 84 of the outer cap-like portion 80, extending down into the second portion 40 as shown. As discussed above, the movement of the movable structure 64 to the second deployed position may cause a frangible moisture barrier 70 (if included) to be ruptured, and effect the placement of the porous pad 68 in pressure contact with the swabbing pad 54. Referring now to Figs. 5 through 8, there is illustrated therein another embodiment of the present invention. As clearly shown, a detector cap assembly 130 may include a first portion 132, a second portion 140, and a spacer 160. As with earlier embodiments, the first portion 132 is structured to mate (e.g., via a friction-fit) with a detector head assembly 12a, which as illustrated may be configured with a female detector head housing 20b. Accordingly, the first portion 132 of the detector head assembly 130 is structured to be inserted into a portion of the detector head housing 20b, as shown in Figs. 6A and 6B. A transparent window 14 of this alternate embodiment is recessed from the opening of the detector head assembly 12a, as can be best seen in Figs. 7B and 7C. As with earlier embodiments of the invention, the structure of this alternate embodiment places a porous pad, as shown in Fig. 7C, in close proximity to the photo-detection means, such as a semiconductor photodetector 124. Again, this arrangement, wherein a porous pad, such as swabbing pad 54 or porous pad 68, is situated proximate to and superposed over a photo-detection means of a suitable luminometer, enables the efficient detecting and quantifying of low level luminescent emissions emitted, at least in part, from one or more of the porous pads .

Turning to Figs. 5, 6A, and 6B, once the detector cap assembly 130 is fixed to the detector head assembly 12a, the second portion 140 and the spacer 160 may be detached or separated from the first portion 132. Once the second portion 140 is separated from the spacer 160, as can be seen in Fig. 6B, a swabbing pad 54 (i.e., a second porous pad) that is coupled to the second portion 140 is available to swab a test surface and attempt to collect analyte therefrom. The second portion 140 would then be mated directly to the first portion 132, which is presently installed on the detector head assembly 12a. As can be seen in Fig. 7C, when the first portion and second portion are mated directly to each other, a pressure contacting occurs between the swabbing pad 54 of the second portion 140 and the porous pad 68 of the first portion 132. An important feature of the present embodiment is the sensing of the luminescent emissions as they are emitted from the porous pad 68. This is in contrast to earlier embodiments wherein the luminescent emissions were sensed from a second surface of the swabbing pad 54.

As with earlier embodiments, the pressure contacting may result in an assaying reaction producing low-level luminescent emissions that may be detected and quantified in accordance with the present invention. As indicated above, since the swabbing pad 54 is coupled to the second portion 140, the swabbing pad 54 of this embodiment, may be termed a 'second porous pad' (as it is fixed or coupled to the second portion) . Similarly, the porous pad 68 of this embodiment may be termed 'a first porous pad'. Referring to Figs. 7A and 7B, illustrated therein are sectional side views of an embodiment of the detector cap assembly 130 and a detector head assembly 12a, taken along the lines 7A-7A and 7B-7B, respectively, of Fig. 5. These sectional views are consistent with the embodiment of Figs. 5, 6A, and 6B, and as such are representative of one possible internal structure that may be utilized with this embodiment. As can be seen in Fig. 7A, the first portion 132 is structured to support a porous pad 68 (impregnated with dried reagents) . As illustrated, the porous pad 68, which may be termed a first porous pad, may preferably be supported at the beginning or right end of the first portion 132, which first enters the detector head housing 20b. As depicted in Fig. 7A, the porous pad 68 may be provided with a somewhat concaved shape. The spacer 160 is structured to be interposed between and suitably mated to the first portion 132 and the second portion 140. As such, the spacer is included to provide for the suitable long term storage of a detector cap assembly 130, while maintaining a required separation between the first and second porous pads until the swabbing of a test surface is desired. As shown, a (first) moisture barrier 70a is included within the spacer 160. As skilled persons will appreciate, it is the combination of the moisture barrier 70a and a second barrier 78 of the first portion that may be configured to provide a desired hermetic seal of the porous pad 68 to prevent moisture, contaminates, etc., from reaching the porous pad 68 before it is intended for use in pressure contacting with the swabbing pad 54. In a like fashion, when the second portion 140 is removably fixed to the spacer 160, as illustrated in Fig. 7A, the swabbing pad 54 may be contained in a sealed environment, preventing wetting agents that are employed to pre-wet the swabbing pad 54 from evaporating and or being contaminated.

Yet another embodiment of the detector cap assembly 130a is illustrated in Fig. 8. This embodiment provides several additional features to earlier embodiments of the detector cap assembly. For example, as skilled persons will appreciate, the efficiency of the detecting of low level luminescent emissions may be enhanced further by including at least one additional photo-detection means. As shown in dotted lines, a second semiconductor photodiode 124a may be included within an internal cavity 144 the second portion 140. As illustrated the semiconductor photodiode 124a may be situated proximate to and superposed by the second porous pad provided by swabbing pad 54, which enables the efficient detecting and quantifying of available low level luminescent emissions emitted therefrom. Accordingly, the embodiment of Fig. 8, may enable the sensing of luminescent emissions emitted from a each of the non- contacting surfaces or sides of the first and second porous pads. Also shown in Fig. 8 is a modified porous pad 68a, which is structured having a deeper concave or what may be termed a 'deep concaved shape' . For example, a preferred concave may provide for a concaved depth of that is 5% to 30% (or more) of the diameter of the first porous pad.

Returning again to Fig. 7B, an electronic shutter, or an equivalent function, may also be provided within detector head housing 20/20a of the detector head assembly 12. Although a mechanical shutter may be employed with the present invention, the use of electronic shutter 120 reduces the mechanical complexity and the cost of construction for preferred embodiments of the detector head assembly 12/12a.

A preferred embodiment of an electronic shutter 120 (as illustrated) , which when included is preferably superposed over and abutting the semiconductor photodiode 124 and immediately below or behind the transparent window 14, is best seen in Fig. 7B. Importantly, the window 14 of the detector head housing 20b is the only avenue for luminescent emissions to be incident upon and detected by the photodiode 124. This first embodiment of the electronic shutter 120 is configured to be set to one of either a darkened state thereby significantly restricting the level of luminescent emissions incident upon the photodiode 124 and a nearly transparent state enabling available luminescent emissions to reach and be detected by the photodiode 124. The term 'significantly restricting', as applied to the level of emissions reaching the photodiode 124 when the electronic shutter 120 is in the darkened state, may be assumed to indicate that the level of emissions reaching and detected by the photodiode 124 may be reduced to a level of 1/lOOth to 1/lOOOth of the level incident when the electronic shutter 120 is in the nearly transparent state. The capability to significantly reduce the level of emissions reaching the photodiode 124 is desirable for a number of reasons well understood by skilled persons. A most preferred version of the electronic shutter 120 may be provided by a polarizing liquid crystal shutter, also known as an LCD shutter. By including suitable electronic couplings (e.g., electrical conductors and connectors), circuitry of a suitable luminometer may be employed to control one or more included the electronic shutters 120. It may be noted that in order to not obfuscate the essential functional and operational characteristics of the various embodiments of the invention as illustrated, certain required and known items and or structures have been omitted. For example, in Figs. 4B and 7B electrical couplings from the semiconductor photodiode 124 have been omitted. Similarly, the electrical couplings required for semiconductor photodiode 124a, if included, have been omitted. These items may certainly be provided by skilled individuals.

A possibly most preferred embodiment of an electronic shutter may alternately be provide wherein the effect of reducing the luminescent emissions entering the luminometer is simulated by a simple microswitch. In such an embodiment the microswitch may be arranged to detect when a detector cap assembly of the invention is, for example, removed from the detector head housing. Such a switch may simply electronically disconnect one or more outputs of the photodiode from an input of amplifiers normally coupled to the photodiode. The input (s) of the amplifier may simple be switched to ground, or alternately connected to a selected reference voltage, when the electronic shutter is activated. This arrangement will enable the ambient light that is being detected by the photodiode (when the detector cap assembly is not fixed to the detector head housing) to be 'electronically' blocked - providing a shutter-type effect.

An important feature of the present invention, which is clearly shown in Fig. 9, may be associated with a core structure that is employed with many embodiments of the present invention. It should be noted that not every structure illustrated in Fig. 9 is required for each possible embodiment contemplated. As can be seen a swabbing pad 54 is coupled (either directly or via a support and reading pad 56) to a suitable wall or support structure 240. A photo-detection means, such as semiconductor photodiode 124, may be provided and situated for the efficient detecting of low level luminescent emissions emitted from a second surface 54b of the swabbing pad 54. A second (opposing) structure provides a porous pad 68, which is suitably supported (as illustrated) by a wall or support structure 250. In addition, at least one other photo-detection means, such as semiconductor photodiode 124a, may be provided for the efficient detecting of low level luminescent emissions emitted directly from the porous pad 68. Importantly, as with other embodiments, the swabbing pad 54 and the porous pad 68 must be configured to be brought into pressure contact within a light-tight environment 180 (conceptually shown in a dotted line) . Should the embodiment of Fig. 9 include both semiconductor photodiodes 124 and 124a, a possibly most efficient and possibly most preferable detection of low level luminescent emissions may be realized by sensing luminescent emissions from each outer, non- contacting side of the pressure contacting first and second porous pads .

As skilled persons will understand, the configuration of the swabbing pad 54 and the porous pad 68, along with the needed support and wall structures, may be provided with embodiments similar to those of Figs. 1 through 4B, Figs. 5 through 8, or yet other possible arrangements. Accordingly, the structure of Fig. 9 may be assumed to be define a preferred embodiment of a central portion the present invention in a broad and functional form.

Turning again to Fig. 9, yet another feature of the present invention is shown. As depicted a preferably substantially flattened support and reading pad 56 having a first surface 56a may be coupled to the second surface 54b of the swabbing pad 54 (or equivalently, and not illustrated, to the porous pad 68) . The support and reading pad 56 would most preferably be provided by a material having a bright, reflective coloring, and a high porosity or openness of approximately 80% to 95%. The first surface 56a of the support and reading pad 56 may be said to be superposed by the second surface 54b of the swabbing pad 54, as shown. As discussed above, a first portion such as first portion 32 may be structured with a wall portion 34 and a second (transparent) barrier 78, which may be considered a means to support the support and reading pad 56, and therefore indirectly the swabbing pad 54. The structure of Fig. 9 is specifically contemplated to enable the swabbing of a test surface and subsequently facilitate the detecting, in a light-tight environment, of any low level luminescent emissions emitted, at minimum, from a second side 56b of support and reading pad 56. This is similar to the function of previous embodiments, with the exception that the direct detecting of luminescent emissions of previous embodiments was made from the second surface 56b of the support and reading pad 56.

It may be noted that the swabbing pad 54 may be said to be 'coupled' to a suitable support structure, such as a first portion 32 or a second portion 40, via the support and reading pad 56. As such, the term 'coupled' may indicate that a respective first, second, or other pad is not directly fixed to such a support structure.

The inclusion of the support and reading pad 56, as depicted in Fig. 9, may provide several functional improvements. For example, the support and reading pad 56 may be formed of a material having an increased openness, yet may further be embodied to be stiffer (or firmer) than the material utilized to provide the swabbing pad 54. As such, when the pressure contacting of the porous pad 68 occurs, at least a portion of the wetting agent solution (including reagents and analyte) is absorbed by and moved into the support and reading pad 56. Therefore, the swabbing structure of Fig. 9 may provide for an improved ability to detect and quantify the luminescent emissions of the assaying reaction, primarily due to an increased portion of the assaying reaction possibly occurring in a very porous, firm, and reflectively colored support and reading pad 56. The support and reading pad 56 may be said to have a high 'reflective porosity', preferably greater than of equal to the swabbing pad 54 and the porous pad 68.

Another important feature of the present invention is also shown in an exemplary form in Fig. 9. The embodiment of a second barrier 78a may be provided having a small pocket 79 formed between the second surface 56b of the support and reading pad 56 and the barrier 78a. This pocket 79 may be useful in enhancing the emissions generated and transmitted directly to the photodiode 124 by a liquid phase (or layer) situated in the pocket 79 while the swabbing pad 54 is compressed. It may be noted that the pocket 79 may be provided with any of the embodiments of the present invention, regardless of weather the support and reading pad 56 is actually included.

Although the porous pad 68 and the swabbing pad 54 are each primarily illustrated as being formed of a single monolithic material, this need not be the case. Accordingly, it is contemplated that each of these porous pads, as well as others included with the various embodiments of the invention, may actually be provided as multi-layer structures, with a plurality of porous pad members stacked or superposed one over the other. For example, as shown in Fig. 10, the second pad may be provided by porous pad 68 overlaying or superposing porous pad 68a. As such, the second porous pad may include multiple layers with individual layers possibly containing different reagents, buffering agents, etc. Such a porous pad may be termed a 'multi-layer porous pad' .

While there have been described a plurality of the currently preferred embodiments of the present invention, along with varied methods of operation, those skilled in the art will recognize that other and further modifications may be made without departing from the invention, and it is intended to claim all modifications and variations as fall within the scope of the described invention and the appended claims .

Claims

ClaimsWhat is claimed is:

1. An analyte collection and assaying assembly, comprising:

(a) a first porous pad coupled to a first portion of the assembly, the first portion structured to be removably fixable to a luminometer so that a second surface of the first porous pad is situated proximate to and superposed over a photo- detection means of the luminometer for detecting and quantifying low level luminescent emissions emitted, at least in part, from the first porous pad; and

(b) a second porous pad coupled to a second portion of the assembly, the second portion structured to be removably fixable to the first portion so as to form an internal light- tight environment that houses the first porous pad and the second porous pad;

(c) the analyte collection and assaying assembly structured to bring the first porous pad into pressure contact with the second porous pad within the internal light-tight environment formed in substantial part by the first portion and the second portion after a test surface has been swabbed with one of either the first porous pad or the second porous pad, the pressure contacting possibly resulting in an assaying reaction producing detectable low level luminescent emissions that may be detected and efficiently quantified by the luminometer.

2. The assembly in accordance with claim 1, wherein the first porous pad of the first portion is provided by one of :

(a) a pre-wetted swabbing pad having a first surface and a second surface, with the first surface structured to swab a test surface after the first portion is separated from the second portion; and

(b) a porous pad impregnated with dried reagents, the porous pad arranged for pressure contacting a pre-wetted swabbing pad after the swabbing pad has been employed for swabbing a test surface.

3. The assembly in accordance with claim 1, wherein the second porous pad of the second portion is provided by one of:

(a) a porous pad impregnated with dried reagents that is arranged for pressure contacting a pre-wetted swabbing pad coupled to the first portion; and

(b) a pre-wetted swabbing pad having a first surface and a second surface, with the first surface structured to swab a test surface when separated from the first portion.

4. The assembly in accordance with claim 1, wherein a second photo-detection means is included and superposed by a second surface of the second porous pad, the second photo-detection means supporting the efficient detecting and quantifying of low level luminescent emissions emitted from the second surface of the porous pad.

5. The assembly in accordance with claim 4, wherein the porous pad impregnated with dried reagents is structured with a concaved pressure contacting surface.

6. The assembly in accordance with claim 1, wherein the porous pad impregnated with dried reagents is structured as a multilayer porous pad.

7. The assembly in accordance with claim 1, further including a support and reading pad, with a second surface of the first porous pad coupled to a first surface of a support and reading pad, with the second surface of the support and reading pad superposed over the photo-detection means of the luminometer.

8. The assembly in accordance with claim 7, wherein a small pocket is provided between the second surface of the support and reading pad and a moisture barrier that is provided between the support and reading pad and the photo-detection means, the pocket provided to support a liquid phase situated in the pocket while the swabbing pad is compressed and pressure contacting the second porous pad.

9. The assembly in accordance with claim 1, wherein the first porous pad and the second porous pad are provided with each having a porosity in the range of 60 to 95 percent.

10. A method of swabbing a test surface in order to collect and indicate the presence of an analyte, the method comprising the steps of:

a) swabbing the test surface with a pre-wetted swabbing pad structured having a first surface and a second surface, with the first surface shaped and configured for contacting the test surface to collect therefrom available analyte;

b) establishing a light-tight environment;

c) bringing the first surface of the swabbing pad into pressure contact with suitable dried reagents possibly causing a detectable low level luminescent reaction, within the light- tight environment, if sufficient analyte has been collected by the swabbing of the test surface; and

d) efficiently detecting and quantifying low level luminescent emissions being emitted from the second surface of the swabbing pad, if the luminescent emissions are produced at a detectable intensity.

11. The method in accordance with claim 10, wherein the dried reagents are impregnated into a porous pad, with the porous pad compressing the swabbing pad causing the activating of the dried reagents therein, and further causing a reduction in a distance between at least one portion of the first surface of the swabbing pad and the second surface thereof, enabling the efficient detecting of emitted low level luminescent emissions by a detection means positioned proximate to and superposed by the second surface of the swabbing pad.

12. The method in accordance with claim 11, wherein a support and reading pad is provided having a first surface coupled to the second surface of the swabbing pad, the first surface of the support and reading pad superposed by the second surface of the swabbing pad, with the support and reading pad thereby interposed and sandwiched between the swabbing pad and the detection means .

13. The method in accordance with claim 12, wherein the support and reading pad is coupled to a support structure to enable the support and reading pad to support the swabbing pad, with the support and reading pad positioned over and substantially covering the detection means, enabling the detecting of the low level luminescent emissions of an assaying reaction when the low level luminescent emissions are being emitted, at least in part, from a second surface of the support and reading pad.

14. The method in accordance with claim 12, wherein the support structure that enables the swabbing pad and the support and reading pad to be positioned over the detection means is provided by a detector cap assembly, with the support and reading pad coupled to a first portion of the detector cap assembly.

15. A method of collecting analyte from a test surface and quantitatively indicating the presence of said analyte, the method comprising the steps of:

a) swabbing the test surface with a pre-wetted swabbing pad employing a first surface of the swabbing pad for contacting the test surface to collect available analyte;

b) bringing the first surface of the swabbing pad into pressure contact with dried reagents, within a darkened light- tight environment, compressing the swabbing pad and possibly causing a detectable low-level luminescent reaction to commence; and

(c) detecting and quantifying, in the darkened light-tight environment, low level luminescent emissions emitted, at least in part, from the swabbing pad.

16. The method in accordance with claim 15, wherein the emitting and sensing of the low level luminescent emissions occurs by way of a second surface of the swabbing pad.

17. The method in accordance with claim 16, wherein a porous pad is provided having the dried reagents impregnated therein, with the porous pad brought into pressure contact with the first surface of the swabbing pad in the light-tight environment.

18. The method in accordance with claim 17, wherein the first surface and a second surface of the swabbing pad are compressed with the distance between at least one portion of the first surface and the second surface being substantially reduced with the pressure contacting of the porous pad and the swabbing pad, enabling an efficient detection of any emitted low level luminescent emissions by a detection means efficiently positioned proximate to the second surface of the swabbing pad.

19. The method in accordance with claim 17, wherein a substantially flattened support and reading pad is provided interposed between the second surface of the swabbing pad and the detection means, with a first surface of the support and reading pad coupled to, and substantially superposed by the second surface of the swabbing pad.

20. The assembly in accordance with claim 17, wherein the porous pad is structured as a multi-layer porous pad.