Bodily fluid analysis system
First Claim
1. A carrier for a diagnostic test strip for use in measuring analyte in a fluid sample, said carrier comprising:
- a carrier body having a test opening enabling said test strip to be observed;
a test strip well formed around said test opening, said well having an upward sloping well wall completely encircling said test opening, the bottom of said well forming a test strip support;
a cover having a sample opening, said cover including an outwardly projecting flange completely encircling said sample opening; and
engagement elements on said carrier body and said cover configured to engage said cover to said carrier body with said sample opening aligned over said test opening with the test strip secured between the distal end of said flange and said test strip support.
5 Assignments
0 Petitions
Accused Products
Abstract
A bodily fluid analyzer including a test strip holder comprising a base and a snap-on cover which completely enclose the test strip except for a sample port in the cover and a sensor port in the base. The test strip is compressed between the base and cover in a sample container having a well-defined sample volume. The test strip comprises a woven dispersement layer, a depth filter containing a reagent, an asymmetrical membrane containing additional reagent, and a colorimetric detection membrane in a vertical stack. The red blood cells are removed from the colorimetric detection area by slowing their vertical movement and stopping flow when the detection membrane is saturated. A minimum value of the reflectance in a color range is used to determine a characteristic of the bodily fluid.
65 Citations
68 Claims
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1. A carrier for a diagnostic test strip for use in measuring analyte in a fluid sample, said carrier comprising:
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a carrier body having a test opening enabling said test strip to be observed;
a test strip well formed around said test opening, said well having an upward sloping well wall completely encircling said test opening, the bottom of said well forming a test strip support;
a cover having a sample opening, said cover including an outwardly projecting flange completely encircling said sample opening; and
engagement elements on said carrier body and said cover configured to engage said cover to said carrier body with said sample opening aligned over said test opening with the test strip secured between the distal end of said flange and said test strip support. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A system for determining a characteristic of a bodily fluid, said system being portable and of a size that can be easily held in a human hand, said system comprising:
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a test strip having a test area and containing a reagent capable of interacting with said bodily fluid to determine said characteristic;
a test strip holder comprising;
a test holder base having a test strip support supporting said test strip and a sensor port communicating with said test strip; and
a test holder cap having a sample port and a projecting flange;
said test holder base and said cap including an engagement mechanism configured to secure said cap to said base with said test strip held between said flange and said test strip support along essentially the entire periphery of said test area. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23)
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24. A system for determining a characteristic of a bodily fluid, said system being portable and of a size that can be easily held in a human hand, said system comprising:
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a test strip containing a reagent capable of interacting with said bodily fluid to determine said characteristic; and
a test strip holder comprising;
a test holder base having a sensor port communicating with said test strip; and
a test holder cap having a sample port communicating with said test strip;
said test holder cap secured to said test holder base with said cap and base completely enclosing said test strip except for said ports. - View Dependent Claims (25, 26, 27, 28, 29)
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30. A method of manufacturing a system for determining a characteristic of a bodily fluid, said system being portable and of a size that can be easily held in a human hand, said method comprising:
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providing a base having a sensor port, a cap having a sample port, and a test strip;
placing said test strip on said base; and
securing said cap to said base to form a container completely enclosing said test strip except for said ports. - View Dependent Claims (31, 32, 33, 34, 35)
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36. A system for determining a characteristic of a bodily fluid, said system being portable and of a size that can be easily held in a human hand, said system comprising:
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a container having a sidewall and a bottom enclosing a test volume wherein said sidewall and bottom are essentially impervious to liquid, and at least a portion of said sidewalls or bottom is permeable to gas;
a sample port above said container and communicating with said container;
a sensor port communicating with said bottom; and
a dry test strip in said test volume, said dry test strip containing a reagent capable of interacting with said bodily fluid to determine said characteristic. - View Dependent Claims (37, 38, 39, 40, 41, 42, 43, 44, 45, 46)
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47. A method of manufacturing a device for testing of bodily fluids, said method comprising:
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providing a test strip, said test strip impregnated with chemicals capable of a predetermined colorimetric response to a predetermined bodily fluid, said test strip having sufficient surface tension with respect to said bodily fluid so that said predetermined bodily fluid will pass into said test strip, but not out of it;
forming a container having a container bottom and a sensing port formed in said container bottom; and
placing said test strip in said container so that it covers said sensing port. - View Dependent Claims (48, 49, 50)
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51. A system for determining a characteristic of a bodily fluid, said system being portable and of a size that can be easily held in a human hand, said system comprising:
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a container having a sidewall and a bottom enclosing a test volume and a sample port, wherein said sidewall and bottom being essentially impervious to liquid;
an asymmetric porous membrane within said test volume; and
a dry test strip in said test volume, said dry test strip containing a reagent capable of interacting with said bodily fluid to determine said characteristic. - View Dependent Claims (52, 53)
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54. A system for determining a characteristic of a bodily fluid, said system being portable and of a size that can be easily held in a human hand, said system comprising:
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a housing defining a test volume;
a sample port in fluidic communication with said test volume;
a test strip assembly comprising a first test layer, a second test layer, and a third test layer;
said first test layer being closer to said sample port than said second test layer, and said third test layer being farther from said sample port than said second test layer;
said first test layer comprising a woven material;
said second test layer comprising non-woven fibers;
said third test layer comprising an asymmetric membrane; and
a reagent in said test volume, said reagent capable of interacting with said bodily fluid to determine said characteristic. - View Dependent Claims (55, 56, 57, 58, 59, 60, 61)
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62. A method for determining a characteristic of a bodily fluid;
- said method comprising;
applying a bodily fluid to a portable testing system that can be easily held in a human hand and which includes a sample container containing a test strip;
permitting said bodily fluid to flow vertically downward into said container;
stopping the flow of said bodily fluid in said container;
reacting a portion of said bodily fluid to create an optical indicator of a parameter of said bodily fluid; and
reading said optical indicator without removing said bodily fluid or said test strip from said container. - View Dependent Claims (63, 64, 65)
- said method comprising;
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66. A method for determining a characteristic of a bodily fluid;
- said method comprising;
applying a bodily fluid to a portable testing system that can be easily held in a human hand and which includes a sample container containing a test strip;
reacting a portion of said bodily fluid to create an optical indicator of a parameter of said bodily fluid;
reading a minimum value of said optical indicator over time; and
utilizing said minimum value to determine said characteristic of said bodily fluid. - View Dependent Claims (67, 68)
- said method comprising;
Specification