초록 ▼

A diagnostic test device comprising at least one membrane disposed in any of one, two, and three dimensions; at least one test sample fluid input port that receives and transfers at least one test sample fluid and onto the at least one membrane; at least one contiguous fluid flow manifold within the

A diagnostic test device comprising at least one membrane disposed in any of one, two, and three dimensions; at least one test sample fluid input port that receives and transfers at least one test sample fluid and onto the at least one membrane; at least one contiguous fluid flow manifold within the at least one membrane to multiplex or distribute the at least one test sample fluid; at least one contiguous fluid flow channel that operatively connects the at least one membrane to the at least one contiguous fluid flow manifold; at least one analyte assay test zone disposed within the at least one contiguous fluid flow channel; and at least one chemical capturing reagent disposed within the at least one analyte assay test zone, wherein multiple analyte assay test results are simultaneously obtained and in parallel in the diagnostic test device.

대표청구항 ▼

1. A lateral flow and flow thru assay device comprising: a) at least two membrane analyte assay substrates positioned in parallel rows in different planes;b) a plurality of fluid flow channels within each of said two membrane analyte assay substrates;c) at least one lateral flow and flow thru assay

1. A lateral flow and flow thru assay device comprising: a) at least two membrane analyte assay substrates positioned in parallel rows in different planes;b) a plurality of fluid flow channels within each of said two membrane analyte assay substrates;c) at least one lateral flow and flow thru assay embedded in each of said fluid flow channels;d) at least one test sample pad on each of said membrane analyte assay substrate, said at least one test sample pad receiving and transferring said at least one test sample fluid to said plurality of flow channels and at least one lateral flow assay and flow thru assay on each of said membrane analyte assay substrates;(e) at least one contiguous fluid flow manifold within said at least one membrane analyte assay substrate to distribute said at least one test sample, from said test sample application pad to said plurality of lateral flow and flow thru assays;f) a marker pad positioned next to and distally to each of said sample pads but before said at least one lateral flow assay of each of said membrane platforms, said marker pad allowing for labeling of analytes of said sample;g) at least one analyte assay test zone disposed on each of said lateral flow and flow thru assay: each of said analyte assay test zones being positioned downstream from said marker pad, wherein each of said analyte test zones are positioned on a different in-line horizontal location from any other said analyte test zones of said lateral flow assays of said at least two membrane analyte assay substrates;h) at least one capture reagent disposed at each of the analyte test zones wherein multiple analyte assay test results are simultaneously obtained and in parallel in said diagnostic test device,wherein said lateral flow and flow thru assays on said membrane analyte assay substrates and said analyte assay test zone are positioned to form a readable barcode, and wherein said dispersal of said capture reagent being dispersed in varying band widths to intensity of the color as calibrated by known reagents to allow for a quantitative measurement of the analytes being tested. 2. The lateral flow and flow thru assay device of claim 1, wherein analyte assays are simultaneously conducted on multiple, independent test sample fluids. 3. The lateral flow and flow thru assay device of claim 1, wherein multiple chemical capture reagent compounds are used simultaneously to conduct multiple, distinct, independent analyte assays. 4. The lateral flow and flow thru assay device of claim 1, further comprising at least one quality control zone operatively connected to said at least one analyte assay test zone, wherein at least one chemical capturing control reagent is applied in said at least one analyte assay test zone. 5. The lateral flow and flow thru assay device of claim 1, further comprising at least one sensor imbedded into said at least one contiguous fluid flow channel, wherein an alteration of a state of said at least one sensor indicates information regarding environmental factors affecting a validity of said diagnostic test device. 6. The lateral flow and flow thru assay device of claim 1, wherein at least one different chemical capture reagent is applied in said at least one analyte assay test zone, and wherein a presence of targeted analytes is indicated, and quantitatively measurable in said at least one analyte assay test zone. 7. The lateral flow and flow thru assay device of claim 1, wherein said at least one chemical capture reagent is applied in different titrations in said at least one analyte assay test zone, and wherein a presence of targeted analytes is indicated, and is quantitatively measurable in said at least one analyte assay test zone by means of a bar code reader. 8. The lateral flow and flow thru assay device of claim 1 , wherein said any of said multiplexed assay and said multiplexed assay array is imbedded within machine-readable codes comprising a barcode, wherein said machine-readable codes comprise: a) test data; b) test validity; c) test type; and d) test parameters, and wherein said multiple analyte assay test results are indicated by alterations of at least one code within said machine-readable codes. 9. The lateral flow and flow thru assay device of claim 1, wherein said at least one contiguous fluid flow manifold and said at least one contiguous fluid flow channel are formed by the method selected from the group consisting of masking, writing, filling, imbedding, printing, etching, lithography, striping, mechanically forming, laser forming, electron beam forming, ion beam forming, stencil forming, thermoforming, molding, and extruding. 10. The lateral flow and flow thru assay device of claim 1, wherein said at least one contiguous fluid flow channel conserves test sample fluid volume. 11. The lateral flow and flow thru assay device of claim 1, wherein said at least one membrane analyte assay substrates further comprises; a) a hydrophilic membrane platform; b) a hydrophobic membrane platform; wherein two said hydrophilic membranes platform are separated by at least one said hydrophobic membrane platform. 12. The lateral flow and flow thru assay device of claim 1, wherein said at least one membrane analyte assay substrates comprises a hydrophilic membrane platform sandwiched between two hydrophobic membrane platforms. 13. The lateral flow and flow thru assay device of claim 12, wherein said hydrophilic membrane platform and said hydrophobic membrane platform are interleaved, wherein a plurality of the interleaved platforms are repeatedly stacked to create a three-dimensional multiplexed analyte assay array structure. 14. The lateral flow and flow thru assay device of claim 1, further comprising a barcode comprising machine-readable codes, said codes comprising said multiplexed analyte assay array imbedded therein, wherein said machine-readable codes comprise: a) test sample fluid identifying information;b) test data;c) test validity;d) test type; ande)test parameters, wherein said multiple analyte assay test results are indicated by alterations of at least one code within said machine-readable codes. 15. The lateral flow and flow thru assay device of claim 1, further comprising: a barcode structure comprising machine-readable codes comprising said any of at least one multiplexed analyte assay and at least one multiplexed analyte assay array imbedded therein, wherein said machine-readable codes comprise: first data regarding said diagnostic test device comprising any of pre-testing data, test types, lot number, identification number, date of manufacture, date of expiration, environmental factors affecting validity of said multiple analyte assay test results, bounds on operational parameters of said diagnostic test device; and second data regarding said analyte assay test results and validity information of said diagnostic test device after said diagnostic test device has been used; and means for transmitting said first data and said second data to authorized databases and web portals. 16. The lateral flow and flow thru assay device of claim 1, further comprising a case in which to support the membrane analyte assay substrates in parallel position to each other.