Chemical apparatus and process disinfecting – deodorizing – preser – Analyzer – structured indicator – or manipulative laboratory... – Chemiluminescent
Reexamination Certificate
2000-02-22
2001-12-11
Wallenhorst, Maureen M. (Department: 1743)
Chemical apparatus and process disinfecting, deodorizing, preser
Analyzer, structured indicator, or manipulative laboratory...
Chemiluminescent
C422S051000, C422S051000, C422S051000, C422S067000, C422S067000, C422S082080, C422S105000, C422S940000, C436S165000, C436S169000, C436S170000, C436S172000, C435S288700, C250S36100C
Reexamination Certificate
active
06328931
ABSTRACT:
TECHNICAL FIELD
The present invention relates generally to swabbing and related structures 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 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. Once a sample has been collected (say with a cotton tipped swab), the sample is assayed by exposure to suitable enzymes and reagents to cause the luminescent emissions-producing reaction to occur. The art provides many examples of luminometer apparatus that are employable in a lab or testing facility to measure emissions of such an assaying reaction. However, these assaying arrangements are not provided in self-contained and highly portable architectures structured for the “efficient detecting” of low-levels of luminescent emissions in accordance with the present invention. Therefore, 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. In addition, known swabbing structures and associated assaying arrangements do not provide simple, self-contained, and efficient structures to collect a sample of analyte, initiate an assaying reaction (in a light-tight environment), and subsequently sense and quantify the low levels of luminescent emissions produced by the reaction.
Accordingly, 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 a suitable light-tight assaying environment (i.e., enclosure), include required chemical and biological materials to initiate the assaying reaction, and further enable or support the efficient quantifying of the low level luminescent emissions produced by the assaying reaction. If properly quantified, the actual (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 the 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 fixed 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 fixed thereto. The second portion is specifically configured to be removably fixed to the first portion to establish the light-tight environment. The light-tight environment houses the first porous pad and the second porous pad to enable the detection of the low level luminescent emissions free of any incident ambient light reaching either 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 (fixed to the first portion) into pressure contact with the second porous pad (fixed 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.
The detector cap assembly may be embodied with the first porous pad of the first portion provided as a swabbing pad, or alternately a reagent holding or impregnated porous pad. Accordingly, the second porous pad would be provided to compliment the first porous pad. For example, if the first porous pad is provided as a reagent impregnated porous pad, then the second porous pad would be provided as a pre-wetted swabbing pad arranged to swab the test surface when separated from the second portion.
The invention further discloses preferred methods for swabbing a test surface in order to collect and quantitatively indicate the presence of an analyte. 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 of another porous pad in a light-tight environment, possibly causing a detectable low level luminescent reaction (if sufficient analyte has been collected).
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Juliano Michael
Silver Lawrence Stanley
International Food Protection, Inc.
Island Patent
Wallenhorst Maureen M.
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