Abstract
A diagnostic testing device for detecting sequences of genetic material and other targeted molecules by collecting at least one sample, purifying and enriching the at least one sample for reverse transcription polymerase chain reaction, performing reverse transcription polymerase chain reaction, and indicating the presence or absence of an at least one targeted molecule or sequence of genetic material. The device is comprised of a housing which is further comprised of an exterior component, an interior component, and a testing assembly disposed therein. The device is mobile, thereby permitting convenient diagnostic use and effective storage and concealment when not in use, and laboratory-independent, thereby dismissing any need for laboratory technician intervention and input.
Claims
1. A diagnostic testing device for detecting sequences of genetic material comprising: a housing comprising an exterior component disposed in fluid communication with an interior component through at least one inlet, said at least one inlet configured to accept at least one sample therein; and said housing further comprising a testing assembly disposed therein, said testing assembly comprising a plurality of components serially disposed in fluid communication for the flow of a sample therethrough, said plurality of components comprising: an entrance component comprising a sample collection element structurally configured to receive at least one sample, a mixing component comprising a mixing pad, said mixing pad comprising at least one mixing composition formulated to mix with a filtered sample, a reaction component comprising a reaction matrix, and a results component comprising at least one indication element.
2. The device of claim 1, wherein said sample collection element comprises a filter assembly configured to convert the sample into the filtered sample as it flows therethrough.
3. The device of claim 2, wherein said filter assembly comprises at least one fluid channel having a plurality of micropores disposed therein.
4. The device of claim 1, wherein said at least one mixing composition comprises a buffer component, said buffer component comprising at least one buffer, and a reactant component, said reactant component comprising at least one reactant.
5. The device of claim 1, wherein said exterior component comprises at least one viewing window, said at least one viewing window configured to indicate detection of sequences of genetic material.
6. A diagnostic testing device for detecting sequences of genetic material comprising: a housing comprising an exterior component disposed in fluid communication with an interior component through at least one inlet, said at least one inlet configured to accept at least one sample therein; and said housing further comprising a testing assembly disposed therein, said testing assembly comprising a plurality of components serially disposed in fluid communication for the flow of a sample therethrough, said plurality of components comprising: an entrance component comprising a sample collection element structurally configured to receive at least one sample, a heating component comprising a heating mechanism, a reaction component comprising a reaction matrix, and a results component comprising at least one indication element.
7. The device of claim 6, wherein said sample collection element comprises a filter assembly configured to convert the sample into a filtered sample as it flows therethrough.
8. The device of claim 7, wherein said filter assembly comprises at least one fluid channel having a plurality of micropores disposed therein.
9. The device of claim 6, wherein said heating mechanism applies convective heat to the interior of said heating component by an exothermic chemical reaction.
10. The device of claim 6, wherein said heating mechanism is configured to produce temperatures generally between about 60° C. and about 75° C.
11. The device of claim 6, wherein said heating mechanism is configured to produce temperatures generally between about 60° C. and about 65° C.
12. The device of claim 6, wherein said exterior component comprises at least one viewing window, said at least one viewing window configured to indicate detection of sequences of genetic material.
13. The device of claim 6, wherein said exterior component comprises an actuation device.
14. A diagnostic testing device for detecting sequences of genetic material comprising: a housing comprising an exterior component disposed in fluid communication with an interior component through at least one inlet, said at least one inlet configured to accept at least one sample therein; and said housing further comprising a testing assembly disposed therein, said testing assembly comprising a plurality of components serially disposed in fluid communication for the flow of a sample therethrough, said plurality of components comprising: an entrance component comprising a sample collection element structurally configured to receive at least one sample, a mixing component comprising a mixing pad, said mixing pad comprising at least one mixing composition formulated to mix with a filtered sample, a heating component comprising a heating mechanism, a reaction component comprising a reaction matrix, and a results component comprising at least one indication element.
15. The device of claim 14, wherein said sample collection element comprises a filter assembly configured to convert the sample into the filtered sample as it flows therethrough.
16. The device of claim 15, wherein said filter assembly comprises at least one fluid channel having a plurality of micropores disposed therein.
17. The device of claim 14, wherein said at least one mixing composition comprises a buffer component, said buffer component comprising at least one buffer, and a reactant component, said reactant component comprising at least one reactant.
18. The device of claim 14, wherein said heating mechanism applies convective heat to the interior of said heating component by an exothermic chemical reaction.
19. The device of claim 14, wherein said heating mechanism is configured to produce temperatures generally between about 60° C. and about 75° C.
20. The device of claim 14, wherein said heating mechanism is configured to produce temperatures generally between about 60° C. and about 65° C.
21. The device of claim 14, wherein said exterior component comprises at least one viewing window, said at least one viewing window configured to indicate detection of sequences of genetic material.
22. The device of claim 14, wherein said exterior component comprises an actuation device.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] For a fuller understanding of the nature of the present invention, reference should be had to the following detailed description taken in connection with the accompanying drawings in which:
[0018] FIG. 1 is a schematic, top perspective view of one embodiment of the reverse transcription polymerase chain reaction diagnostic testing device at a slightly downward angle.
[0019] FIG. 2 is a schematic, top perspective view of one embodiment of the testing assembly disposed within the housing of the reverse transcription polymerase chain reaction diagnostic testing device at a slightly downward angle.
[0020] FIG. 3 is a schematic, top perspective view of one embodiment of an attachable member to the testing assembly.
[0021] FIG. 4 is a flow diagram of the various samples identified at different stages within the present invention.
[0022] FIG. 5 is a schematic, top perspective view of another embodiment of the testing assembly disposed within the housing of the polymerase chain reaction diagnostic testing device.
[0023] FIG. 6 is a schematic, top perspective view of another embodiment of the reverse transcription polymerase chain reaction diagnostic testing device at a slightly downward angle.
[0024] Like reference numerals refer to like parts throughout the several views of the drawings.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0025] The invention now will be described more fully hereinafter with reference to the accompanying drawings in which illustrative embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.
[0026] Turning now descriptively to the figures, FIGS. 1, 2, and 3 illustrate an inventive diagnostic testing device configured to detect and diagnose both infectious and non-infectious conditions through utilization of reverse transcription polymerase chain reaction (RT-PCR).
[0027] FIGS. 1, 2, and 3 show that the RT-PCR diagnostic testing device 10 is primarily comprised of a housing 100 which is further comprised of an exterior component 110, an interior component 120, and a testing assembly 200 disposed therein. The exterior component 110 may comprise at least one inlet 112, a first viewing window 113, a second viewing window 114, a third viewing window 115, and an actuation device 116. In one embodiment of the present invention, illustrated in FIG. 6, the exterior component 110 may comprise a protective cap 111, at least one inlet 112, a first viewing window 113, a second viewing window 114′, and an actuation device 116. The testing assembly 200, illustrated in FIG. 2, however, may comprise an entrance component 210, a mixing component 220, a heating component 230, a reaction component 240, a results component 250, and an absorption component 260. In one embodiment of the present invention, illustrated in FIG. 2, the plurality of components comprising the testing assembly 200 are not separate and distinct from one another.
[0028] As disclosed in FIG. 1, the exterior component 110 is disposed in fluid communication with the interior component 120 through the at least one inlet 112, with the at least one inlet 112 configured to accept at least one sample 310 therein, as will be explained in greater detail with reference to FIG. 4. With reference to FIGS. 2 and 4, the entrance component 210 within the testing assembly 200 is comprised of a sample collection element 211, which is structurally configured to receive the at least one sample 310. In one embodiment of the present invention, the device 10 may comprise a sample collection element 211 which extends from the entrance component 210 through both the mixing component 220 and the heating component 230, ending immediately before the reaction component 240. By way of non-limiting example, the at least one sample 310 may be a physiological fluid, such as saliva or blood, originating from species including, but not limited to, humans, animals, bacteria, parasites, enveloped and non-enveloped viruses, yeasts, and molds. In at least one embodiment of the present invention, the at least one sample 310 collected by the sample collection element 211 may volumetrically lie in the range of between generally about 100 to 500 microliters. As used herein, the term “between generally about” refers to the tolerance of values within the standard of error to a person of ordinary skill in the art. As disclosed in FIGS. 2 and 4, the sample collection element 211 is comprised of a filter assembly 315 that may itself comprise at least one fluid channel having a plurality of micropores disposed therein, the filter assembly 315 being configured to convert the at least one sample 310 into a filtered sample 320 as it flows therethrough. By way of non-limiting example, the at least one fluid channel within the sample collection element 211 may comprise paraffin-molded wax channels. With reference to FIGS. 2 and 4, the filter assembly 315 acts simultaneously to facilitate the lateral movement of the at least one sample 310 in one direction via hydrophobic-hydrophilic interactions and to remove any non-targeted components of the at least one sample 310 such that the device 10 can convert the at least one sample 310 into the filtered sample 320 as it passes through the entrance component 210. By way of non-limiting example, the sample collection element 211 may be made of a micro-absorbent paper. In one embodiment, the micro-absorbent paper may comprise specific probes and other nanoparticles with a high affinity to the at least one targeted molecule or sequence of genetic material such that the at least one sample 310 can covalently bond to the specific probes and other nanoparticles.
[0029] With primary reference to FIGS. 2, 4, and 5, the mixing component 220, which is comprised of a mixing pad 221, is structured such that the mixing pad 221, which may comprise at least one mixing composition formulated to mix with the filtered sample 320, will have its contents mix with the filtered sample 320 as the filtered sample 320 interacts with the mixing pad 221. In doing so, the mixing of the at least one mixing composition with the filtered sample 320 results in a mixed sample 330 that may comprise enriched fragments of genetic material. In one embodiment of the present invention, upon assembly of the device 10, the mixing pad 221 may comprise the at least one mixing composition. In another embodiment, the mixing pad 221 may not comprise the at least one mixing composition upon assembly of the device 10. By way of non-limiting example, the at least one mixing composition may comprise a buffer component, the buffer component comprising at least one buffer, and a reactant component, the reactant component comprising at least one reactant. In one embodiment, the reactant component of the at least one mixing composition comprises magnetic beads such that any targeted nucleic acids and other biological molecules can be recognized and captured by hybridization methods. In one embodiment, the preferred time frame to mix the at least one mixing composition and the filtered sample 320 to form the mixed sample 330 is within the range of generally about one to two minutes. As used herein, the term “generally about” refers to the tolerance of values within the standard of error to a person of ordinary skill in the art. In one embodiment of the present invention, upon completion of the mixing of the at least one mixing composition with the filtered sample 320 to result in the mixed sample 330, the first viewing window 113 of the device 10 may be disposed to indicate both completion of the mixing of the at least one mixing composition with the filtered sample 320 and also the readiness of the device 10 to enter a heating phase. In such an embodiment, illustrated in FIGS. 1 and 6, the first viewing window 113 may indicate both completion of the mixing of the at least one mixing composition with the filtered sample 320 and also the readiness of the device 10 to enter a heating phase via a colorimetric reading.
[0030] The heating component 230, which is comprised of a heating mechanism 231, is structured such that the heating mechanism 231 applies heat to the interior of the heating component 230 such that the temperature of the mixed sample 330 is increased, producing a heated sample 340, as represented in FIG. 4. In one embodiment of the present invention, illustrated in FIG. 2, the heating mechanism 231 is distinct and separable from the heating component 230. In another embodiment, illustrated in FIG. 5, the heating mechanism 231′ within the testing assembly 200′ is not separable from the heating component 230′. By way of non-limiting example, the heating mechanism 231 may apply convective heat by an exothermic chemical reaction. In one embodiment, the heating mechanism 231 may be activated through utilization of the actuation device 116. By way of non-limiting example, the actuation device 116 may comprise a depressible button, an electronic control module, or a sensory-sensitive control module. In one embodiment, the heating mechanism 231 is configured to produce temperatures generally between about 60° C. and about 75° C. In another embodiment, the heating mechanism 231 is configured to produce temperatures generally between about 60° C. and about 72° C. In such an embodiment, the preferred temperature to be produced by the heating mechanism 231 is generally about 65° C. In one embodiment, the preferred time frame to produce heat by the heating mechanism 231 is within the range of generally between about fifteen to twenty minutes.
[0031] With primary reference to FIGS. 2, 4, and 5, the reaction component 240, which is comprised of a reaction matrix 241, is structured such that the reaction matrix 241, which may comprise at least one reaction fluid disposed to find the at least one targeted molecule or sequence of genetic material within the heated sample 340, interacts with the heated sample 340 as it flows therethrough in such a way to produce a reacted sample 350 that allows the device 10 to determine whether the at least one targeted molecule or sequence of genetic material is present or absent. In one embodiment of the present invention, the presence of absence of the at least one targeted molecule or sequence of genetic material is visually determined by staining the reacted sample 340 with a chemical dye. By way of non-limiting example, the at least one reaction fluid can have a varying composition such that a wide variety of targeted sequences of genetic material and other molecules can be discoverable via diagnostic testing with the present invention.
[0032] As disclosed in FIGS. 2, 4, and 5, once the heated sample 340 has sufficiently interacted with the reaction matrix 241 such that any actively reacting components within the reaction component 240 have completed reacting, thus producing the reacted sample 350, the results of the performed diagnostic testing can be visualized by the results component 250, which may itself comprise a first indication element 251 and second indication element 252 and which produces a tested sample 360 as it flows therethrough. In one embodiment, the exterior component 110 comprises a second viewing window 114 disposed to indicate completion of an assay and a third viewing window 115 disposed to indicate the presence or absence of the at least one targeted molecule or sequence of genetic material. In such an embodiment, the second viewing window 114 disposed to indicate completion of an assay does so with the first indication element 251, which indicates completion of the assay via a colorimetric reading. Further, in such an embodiment, the third viewing window 115 disposed to indicate the presence or absence of the at least one targeted molecule or sequence of genetic material does so with the second indication element 252, which indicates the presence or absence of the at least one targeted molecule or sequence of genetic material via formation of a signal, usually in the form of a line. In another embodiment, illustrated in FIG. 6, the exterior component 110 comprises a second viewing window 114′ disposed to both indicate completion of an assay via a colorimetric reading with the first indication element 251 and to indicate the presence or absence of the at least one targeted molecule or sequence of genetic material via formation of a signal, usually in the form of a line, with the second indication element 252.
[0033] Once any results are visualized in the at least one viewing window of the exterior component 110 of the device 10, the tested sample 360 continues to laterally flow in the same direction and interacts with the absorption component 260, which may itself comprise an absorbent pad 261. In doing so, the tested sample 360 is absorbed by the absorbent pad 261 in order to collect any of the remaining tested sample 360 and other potential fluids, and to halt the movement of the tested sample 360 as it flows therethrough.
[0034] Since many modifications, variations and changes in detail can be made to the described embodiments of the invention, it is intended that all matters in the foregoing description and shown in the accompanying drawings be interpreted as illustrative and not in a limiting sense. Thus, the scope of the invention should be determined by the appended claims and their legal equivalents.
