A dry reagent delivery system with membrane having porosity gradient

Claim 3

The method of claim 1, wherein the porous membrane is conditioned with an absorption effective amount of a conditioning agent selected from the group consisting of albumin, polyvinyl pyrolidone, polyethylene glycol, carbohydrates, carboxymethyl cellulose (water soluble), methyl cellulose, glycerine and polyoxyethylene ethers.

Claim 4

The method of claim 1, wherein the porous membrane is cast from a material selected from the group consisting of a cellulose acetate-cellulose nitrate ester, nylon and polysulfone.

Claim 5

The method of claim 1, wherein the reagent cocktail is specific for glucose.

Claim 6

The method of claim 1, wherein the reagent cocktail is specific for cholesterol.

Claim 7

The method of claim 1, wherein the reagent cocktail is specific for urea.

Claim 8

The method of claim 1, wherein the reagent cocktail is specific for detection of an antigen or an antibody.

Claim 9

The method of claim 7, wherein the reagent cocktail contains an angiten or antibody which is conjugated to a mimic of an analyte.

Claim 10

The method of claim 7, wherein the reagent cocktail is specific for detection of hormones, pharmaceutical compounds, drugs of abuse or proteinaceous materials which are capable of evoking an immune response.

Claim 11

The method of claim 7, wherein a portion of the reagent cocktail is deposited upon one of the planar surfaces of the porous membrane so as to be retained thereon without substantial penetration into the matrix of the porous membrane.

Claim 12

A dry chemistry reagent system for detection of an analyte in a heterogenous fluid sample, said system comprising: a porous membrane of essentially uniform composition and a porosity gradient from one planar surface thereof to the other, wherein said porous membrane's inherent fluid absorption and distribution characteristics have been modified by imbibing a conditioning agent, an indicator, flow control agent and reagent cocktail into its matrix, the effect of such absorption being to effect an essentially uniform distribution of indicator, flow control agent and reagent cocktail within the porous membrane thereby enhancing the uniformity of internal structure of said film so as to enhance the uniformity of absorption and modulate the rate of absorption of the fluid sample and its interaction with the reagent cocktail.

Claim 13

A dry chemistry reagent system for detection of an analyte in a heterogenous fluid sample, said system comprising: a porous membrane of essentially uniform composition and a porosity gradient from one planar surface thereof to the other, wherein said porous membrane's inherent fluid absorption and distribution characteristics have been modified by imbibing a conditioning agent, an indicator, flow control agent and reagent cocktail into its matrix, the effect of such absorption being to effect an essentially uniform distribution of indicator, flow control agent and reagent cocktail within the porous membrane thereby enhancing the uniformity of internal structure of said film so as to enhance the uniformity of absorption and modulate the rate of absorption of the fluid sample and its interaction with the reagent cocktail.

Claim 14

The system of claim 11, wherein the porous membrane is conditioned with an absorption effective amount of a conditioning agent selected from the group consisting of albumin, polyvinyl pyrolidone, polyethylene glycol, carbohydrates, carboxymethyl cellulose, methyl cellulose, glycerine and polyoxyethylene ethers.

Claim 15

The system of claim 11, wherein the porous membrane is cast from a material selected from the group consisting of a cellulose acetatecellulose nitrate ester, nylon and polysulfone.

Claim 16

The system of claim 11, wherein the reagent cocktail is specific for detection of glucose.

Claim 17

The system of claim 11, wherein the reagent cocktail is specific for detection of cholesterol.

Claim 18

The system of claim 11, wherein the reagent cocktail is specific for detection of urea.

Claim 19

The system of claim 11, wherein the reagent cocktail is specific for detection of an antigen or an antibody.

Claim 20

The system of claim 17, wherein the reagent cocktail contains an antigen or antibody which is conjugated to a mimic of an analyte.

Claim 21

The system of claim 17, wherein the reagent cocktail is specific for detection of hormones, pharmaceutical compounds, drugs of abuse or proteinaceous materials which are capable of evoking an immune response.

Claim 22

The system of claim 17, wherein a portion of the reagent cocktail is deposited upon one of the planar surfaces of the porous membrane so as to be retained thereon without substantial penetration into the matrix of the porous membrane.

Claim 23

A rapid analytical method for screening a heterogenous fluid sample for an analyte of interest, comprising: (a) providing a dry chemistry reagent system comprising a porous membrane of essentially uniform composition and a porosity gradient from one planar surface thereof to the other, wherein said porouse membrane's inherent fluid absorption characteristics have been modified by sequentially imbibing a conditioning agent, an indicator, flow control agent and reagent cocktail into its matrix, the effect of such absorption being to effect an essentially uniform distribution of indicator, flow control agent and reagent cocktail within the porous membrane thereby enhancing the uniformity of internal structure of said porous membrane so as to modulate both the rate and the uniformity of absorption of the fluid sample and its interaction with the reagent cocktail; (b) applying a heterogenous fluid sample to the sample receptive surface of the bibulous medium of the reagent system; and (c) monitoring the surface of the bibulous medium opposite to the sample receptive surface for a change of color or fluorescence or for the development of color or fluorescence.

Claim 24

A rapid analytical method for screening a heterogenous fluid sample for an analyte of interest, comprising: (a) providing a dry chemistry reagent system comprising a porous membrane of essentially uniform composition and a porosity gradient from one planar surface thereof to the other, wherein said porouse membrane's inherent fluid absorption characteristics have been modified by sequentially imbibing a conditioning agent, an indicator, flow control agent and reagent cocktail into its matrix, the effect of such absorption being to effect an essentially uniform distribution of indicator, flow control agent and reagent cocktail within the porous membrane thereby enhancing the uniformity of internal structure of said porous membrane so as to modulate both the rate and the uniformity of absorption of the fluid sample and its interaction with the reagent cocktail; (b) applying a heterogenous fluid sample to the sample receptive surface of the bibulous medium of the reagent system; and (c) monitoring the surface of the bibulous medium opposite to the sample receptive surface for a change of color or fluorescence or for the development of color or fluorescence.

Claim 25

The analytical method of claim 21, wherein the porous membrane is conditioned with an absorption effective amount of a conditioning agent selected from the group consisting of albumin, polyvinyl pyrolidone, polyethylene glycol, carbohydrates, carboxymethyl cellulose, methyl cellulose, glycerine and polyoxyethylene ethers.

Claim 26

The analytical method of claim 21, wherein the porous membrane is cast from a material selected from the group consisting of a cellulose acetate-cellulose nitrate ester, nylon and polysulfone.

Claim 27

The analytical method of claim 21, wherein the reagent cocktail is specific for detection of glucose.

Claim 28

The analytical method of claim 21, wherein the reagent cocktail is specific for detection of cholesterol.

Claim 29

The analytical method of claim 21, wherein the reagent cocktail is specific for detection of urea.

Claim 30

The analytical method of claim 21, wherein the reagent cocktail is specific for detection of an antigen or an antibody.

Claim 31

The analytical method of claim 27, wherein the reagent cocktail contains an antigen or antibody which is conjugated to a mimic of an analyte.

Claim 32

The analytical method of claim 27, wherein the reagent cocktail is specific for detection of hormones, pharmaceutical compounds, drugs of abuse or proteinaceous materials which are capable of evoking an immune response.

Claim 33

The analytical method of claim 27, wherein a portion of the reagent cocktail is deposited upon one of the planar surfaces of the porous membrane so as to be retained thereon without substantial penetration into the matrix of the porous membrane.

Claim 34

A test kit for analysis of a heterogenous fluid sample, said kit comprising: (a) dry chemistry reagent system comprising a porous membrane of essentially uniform composition and a porosity gradient from one planar surface thereof to the other, wherein said porous membrane inherent fluid absorption and distribution characteristics have been modified by sequentially imbibing a conditioning agent, an indicator and reagent cocktail into its matrix, the effect of such absorption being to effect an essentially uniform distribution of indicator, flow control agent and reagent cocktail within the porous membrane thereby enhancing the uniformity of internal structure of said film so as to modulate both the rate and uniformity of absorption of the fluid sample and its interaction with the reagent cocktail; and (b) a standard for comparison with the indicator of the dry chemistry reagent system.

Claim 35

A test kit for analysis of a heterogenous fluid sample, said kit comprising: (a) dry chemistry reagent system comprising a porous membrane of essentially uniform composition and a porosity gradient from one planar surface thereof to the other, wherein said porous membrane inherent fluid absorption and distribution characteristics have been modified by sequentially imbibing a conditioning agent, an indicator and reagent cocktail into its matrix, the effect of such absorption being to effect an essentially uniform distribution of indicator, flow control agent and reagent cocktail within the porous membrane thereby enhancing the uniformity of internal structure of said film so as to modulate both the rate and uniformity of absorption of the fluid sample and its interaction with the reagent cocktail; and (b) a standard for comparison with the indicator of the dry chemistry reagent system.

Claim 36

The test kit of claim 31, wherein the porous membrane is conditioned with an absorption effective amount of a conditioning agent selected from the group consisting of albumin, polyvinyl pyrolidone, polyethylene glycol, carbohydrates, carboxymethyl cellulose, methyl cellulose, glycerine and polyoxyethylene ethers.

Claim 37

The test kit of claim 31, wherein the porous membrane is cast from a material selected form the group consisting of a cellulose acetatecellulose nitrate ester, nylon and polysulfone.

Claim 38

The test kit of claim 31, wherein the reagent cocktail is specific for detection of glucose.

Claim 39

The test kit of claim 31, wherein the reagent cocktail is specific for detection of cholesterol.

Claim 40

The test kit of claim 31, wherein the reagent cocktail is specific for detection of urea.

Claim 41

The test kit of claim 31, wherein the reagent cocktail is specific for detection of an antigen or an antibody.

Claim 42

The test kit of claim 37, wherein the reagent cocktail contains an antigen or antibody which is conjugated to a mimic of an analyte.

Claim 43

The test kit of claim 37, wherein the reagent cocktail is specific for detection of hormones, pharmaceutical compounds, drugs of abuse or proteinaceous materials which are capable of evoking an immune response.

Claim 44

The test kit of claim 37, wherein a portion of the reagent cocktail is deposited upon one of the planar surfaces of the porous membrane so as to be retained thereon without substantial penetration into the matrix of the bibulous film.