US4645744A — Unified test means for ion determination

Claim 1

Independent Claim 69 words

A test means for determining the presence of an ion in an aqueous test sample, the test means comprising: a reagent layer composed of a substantially nonpolar, nonporous carrier matrix incorporated with (a) an ionophore capable of forming a complex with a specific ion to be determined, and (b) a reporter substance capable of interacting with the complex of the ionophore and the ion to produce a detectable response.

Claim 2

Dependent Claim 69 words

A test means for determining the presence of an ion in an aqueous test sample, the test means comprising: a reagent layer composed of a substantially nonpolar, nonporous carrier matrix incorporated with (a) an ionophore capable of forming a complex with a specific ion to be determined, and (b) a reporter substance capable of interacting with the complex of the ionophore and the ion to produce a detectable response.

Claim 3

Dependent Claim 17 words

The test means of claim 1 in which the nonpolar, nonporous carrier matrix is a polymer film.

Claim 4

Dependent Claim 14 words

The test means of claim 2 in which the polymer film includes a plasticizer.

Claim 5

Dependent Claim 46 words

The test means of claim 3 in which the reporter substance is formed by at least two precursor substances incorporated in the nonpolar, nonporous carrier matrix, which formation is caused by the interaction of the precursor substances with the complex of the ionophore and the ion.

Claim 6

Dependent Claim 18 words

The test means of claim 3 in which the polymer film is additionally incorporated with light scattering centers.

Claim 7

Dependent Claim 40 words

The test means of claim 5 in which the light scattering centers are composed of particles selected from the group consisting of titanium dioxide, aluminum oxide, magnesium oxide, calcium carbonate, barium sulfate, zinc oxide, lead oxide, talc and microcrystalline cellulose.

Claim 8

Dependent Claim 82 words

A test means for determining the presence of an ion in an aqueous test sample, the test means comprising a reagent layer composed of a substantially nonpolar, nonporous carrier matrix incorporated with (a) an ionophore capable of forming a complex with a specific ion to be determined; and (b) a neutral reporter compound having a dissociable proton, which proton is capable of dissociating from the reporter upon interaction with the complex of the ionophore and the ion to produce a detectable response.

Claim 9

Dependent Claim 82 words

A test means for determining the presence of an ion in an aqueous test sample, the test means comprising a reagent layer composed of a substantially nonpolar, nonporous carrier matrix incorporated with (a) an ionophore capable of forming a complex with a specific ion to be determined; and (b) a neutral reporter compound having a dissociable proton, which proton is capable of dissociating from the reporter upon interaction with the complex of the ionophore and the ion to produce a detectable response.

Claim 10

Dependent Claim 19 words

The test means of claim 7, which additionally includes a water impervious support member affixed to the reagent layer.

Claim 11

Dependent Claim 16 words

The test means of claim 7 in which the nonpolar, nonporous carrier is a polymer film.

Claim 12

Dependent Claim 14 words

The test means of claim 9 in which the polymer film includes a plasticizer.

Claim 13

Dependent Claim 35 words

The test means of claim 7 in which the reporter substance is one capable of producing the appearance of, or change in, fluorescenee in the presence of the complex of the ionophore and the ion.

Claim 14

Dependent Claim 17 words

The test means of claim 11 in which the reporter substance is fluorescein or a derivative thereof.

Claim 15

Dependent Claim 35 words

The test means of claim 7 in which the reporter substance is one capable of producing the appearance of, or change in, color in the presence of the complex of the ionophore and the ion.

Claim 16

Dependent Claim 70 words

The test means of claim 13 in which the reporter substance is a compound having the structure: ##STR15## in which X, same or different, is a halogen or pseudohalogen; in which each R, same or different, is a 2-, 3-, 5-, or 6-position substitutent, or multiple substituents thereof, selected from the lower alkyl, intermediate alkyl, aryl or fused ring at the 2,3- or 5,6-position; and η is 0 to 4.

Claim 17

Dependent Claim 41 words

The test means df claim 13 in which the reporter substance is a compound having the structure: ##STR16## in which R' is H or lower alkyl, R* is H or intermediate alkyl and X, same or different, is halogen or pseudohalogen.

Claim 18

Dependent Claim 15 words

The test means of claim 15 in which R' is methyl and R* is η-decyl.

Claim 19

Dependent Claim 26 words

The test means of claim 16 in which the specific cation to be determined is potassium ion and the ionophore is composed of valinomycin and 2,3-naphtho-1,4,7,10,13-pentaoxacyclopentadeca-2-ene.

Claim 20

Dependent Claim 109 words

A multilayer test means for determining the presence of an ion in an aqueous test sample, comprising: (a) a reagent layer comprising a substantially non-polar, nonporous carrier matrix incorporated with an ionophore capable of forming a complex with a specific ion to be determined and a reporter substance capable of interacting with the complex of the ionophore and the ion to produce a detectable response, and (b) a reflecting layer disposed on top of the reagent layer and in laminar relationship thereto, said reflecting layer including one or more materials which act as a background in order to facilitate the detection of a detectable response in the reagent layer.

Claim 21

Dependent Claim 109 words

A multilayer test means for determining the presence of an ion in an aqueous test sample, comprising: (a) a reagent layer comprising a substantially non-polar, nonporous carrier matrix incorporated with an ionophore capable of forming a complex with a specific ion to be determined and a reporter substance capable of interacting with the complex of the ionophore and the ion to produce a detectable response, and (b) a reflecting layer disposed on top of the reagent layer and in laminar relationship thereto, said reflecting layer including one or more materials which act as a background in order to facilitate the detection of a detectable response in the reagent layer.

Claim 22

Dependent Claim 38 words

The process of determining unbound calcium, comprising the steps of: (a) contacting the reflecting layer of the multilayer test means of claim 18 with an aqueous test sample; and (b) determining the detectable response in the reagent layer.

Claim 23

Dependent Claim 57 words

The multilayer test means of claim 18 in which the specific ion to be determined is a cation and the reporter is a neutral compound having a dissociable proton, which proton is capable of dissociating from the reporter upon interaction of the reporter with the complex of the ionophore and the ion to produce a detectable response.

Claim 24

Dependent Claim 17 words

The multilayer test device of claim 18 which additionally includes a buffer incorporated with the reflecting layer.

Claim 25

Dependent Claim 19 words

The multilayer test device of claim 18 which additionally includes an interferant removal substance incorporated with the reflecting layer.

Claim 26

Dependent Claim 42 words

The multilayer test means of claim 18 in which the background material in the reflecting layer is composed of particles selected from the group consisting of titanium dioxide, aluminum oxide, magnesium oxide, barium sulfate, zinc oxide, lead oxide, talc and microcrystalline cellulose.

Claim 27

Dependent Claim 17 words

The multilayer test means of claim 23 in which the reflecting layer additionally includes a hydrophilic polymer.

Claim 28

Dependent Claim 18 words

The multilayer test means of claim 18 in which the nonpolar, nonporous carrier matrix is a polymer film.

Claim 29

Dependent Claim 15 words

The multilayer test means of claim 25 in which the polymer film includes a plasticizer.

Claim 30

Dependent Claim 26 words

The multilayer test means of claim 26 additionally comprising a transparent support member laminated to the reagent layer on the side opposed to the reflecting layer.

Claim 31

Dependent Claim 41 words

The multilayer test means of claim 18 additionally comprising an opacifying layer in laminar relationship to the reflecting layer and disposed on top of the reflecting layer, the opacifying layer containing particles for imparting an opaque appearance to the opacifying layer.

Claim 32

Dependent Claim 17 words

The multilayer test means of claim 28 in which the opacifying particles are particles of carbon black.

Claim 33

Dependent Claim 17 words

The multilayer test means of claim 28 in which the opacifying layer additionally includes a hydrophilic polymer.

Claim 34

Dependent Claim 22 words

The multilayer test device of claim 28 which additionally includes a buffer incorporated with the reflecting layer, the opacifying layer or both.

Claim 35

Dependent Claim 24 words

The multilayer test device of claim 28 which additionally includes an interferant removal substance incorporated with the reflecting layer, the opacifying layer or both.

Claim 36

Dependent Claim 119 words

A multilayer test means for determining the presence of an ion in a whole blood sample, comprising: (a) a reagent layer comprising a substantially non-polar, nonporous carrier matrix incorporated with an ionophore capable of forming a complex with a specific ion to be determined and reporter substance capable of interacting with the complex of the ionophore and the ion to produce a detectable response, and (b) a reflecting layer disposed on top of the reagent layer and in laminar relationship thereto, said reflecting layer including one or more materials wlich act as a background in order to facilitate the detection of a response in the reagent layer and sufficient sodium chloride to impart hematocrit independence to the ion determination.

Claim 37

Dependent Claim 119 words

A multilayer test means for determining the presence of an ion in a whole blood sample, comprising: (a) a reagent layer comprising a substantially non-polar, nonporous carrier matrix incorporated with an ionophore capable of forming a complex with a specific ion to be determined and reporter substance capable of interacting with the complex of the ionophore and the ion to produce a detectable response, and (b) a reflecting layer disposed on top of the reagent layer and in laminar relationship thereto, said reflecting layer including one or more materials wlich act as a background in order to facilitate the detection of a response in the reagent layer and sufficient sodium chloride to impart hematocrit independence to the ion determination.

Claim 38

Dependent Claim 165 words

A multilayer test means for determining the presence of an ion in a whole blood sample, comprising: (a) a reagent layer comprising a substantially non-polar, nonporous carrier matrix incorporated with an ionophore capable of forming a complex with a specific ion to be determined and a reporter substance capable of interacting with the complex of the ionophore and the ion to produce a detactable response; (b) a reflecting layer disposed on top of the reagent layer and in laminar relationship thereto, said reflecting layer including one or more materials which act as a background in order to facilitate the detection of a response in the reagent layer; and (c) an opacifying layer in laminar relationship to the reflecting layer and disposed on top of the reflecting layer, the opacifying layer containing particles for imparting an opaque appearance to the opacifying layer; wherein sufficient sodium chloride is incorporated in either the reflecting layer, the opacifying layer or both, to impart hematocrit independence to the ion determination.

Claim 39

Dependent Claim 165 words

A multilayer test means for determining the presence of an ion in a whole blood sample, comprising: (a) a reagent layer comprising a substantially non-polar, nonporous carrier matrix incorporated with an ionophore capable of forming a complex with a specific ion to be determined and a reporter substance capable of interacting with the complex of the ionophore and the ion to produce a detactable response; (b) a reflecting layer disposed on top of the reagent layer and in laminar relationship thereto, said reflecting layer including one or more materials which act as a background in order to facilitate the detection of a response in the reagent layer; and (c) an opacifying layer in laminar relationship to the reflecting layer and disposed on top of the reflecting layer, the opacifying layer containing particles for imparting an opaque appearance to the opacifying layer; wherein sufficient sodium chloride is incorporated in either the reflecting layer, the opacifying layer or both, to impart hematocrit independence to the ion determination.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	1990-02-23	1990-08-25	1991-02-24	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	1994-02-23	1994-08-25	1995-02-24	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	1998-02-23	1998-08-25	1999-02-24	$7700.00	Window Closed / Lapsed

Unified test means for ion determination

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