Apparatus and method for analyses of biological specimens

Claim 2

A kit for use in quantitation of specimen cell objects on each of a plurality of slide, the kit comprising: a microscopic slide, the slide including a reference material are, the reference material area containing a reference means for staining, the reference means having predetermined physical characteristics which are detectable after staining; one or more containers of stain material, the stain material including stain for stain application to the reference means and to specimen cell objects on the plurality of slides, the stain in the containers being in an effective amount to provide an optical density to the reference means after simultaneous staining of the reference means and specimen cell objects so that after the staining, the optical density of the reference means may be compared with an optical density of the specimen cell objects for the quantitation of the specimen cell objects.

Claim 3

A kit as recited in claim 1 wherein the stain is selected from the group consisting of thionin, Azure A, Azure C, congo red, pararosanilin, acriflavine, diaminobenzidine, alkaline phosphatase, eosin, ethyl green, fast green, methyl green, methylene blue, hematoxylin, acridine orange, giemsa and mixtures thereof.

Claim 4

A kit as recited in claims 1 or 2 wherein the reference means includes a reference material selected from the group consisting of rat liver nuclei, trout erythrocytes, chicken erythrocytes, dried DNA, cultured cell lines and mixtures thereof.

Claim 5

A kit as recited in claims 1 or 2 wherein the kit further includes a stain sulfonating agent.

Claim 6

A kit as recited in claim 3 wherein the kit further includes a stain sulfonating agent.

Claim 7

A kit for the quantitation of cell nuclei comprising: a microscopic slide, the slide including a reference area and a specimen call object area for receipt of specimen cell objects, the reference area containing a reference means for staining, the reference means having predetermined physical characteristics which are detectable after staining; and one or more containers of stain material, the stain application to the specimen cell objects and the reference means, the stain in the containers being in an effective amount to provide an optical density to the reference means after simultaneous staining of the reference means and specimen cell objects so that after the staining, the optical density of the reference means may be compared with an optical density of the specimen cell objects for the quantitation of cell nuclei in the specimen cell objects.

Claim 8

A kit for the quantitation of cell nuclei comprising: a microscopic slide, the slide including a reference area and a specimen call object area for receipt of specimen cell objects, the reference area containing a reference means for staining, the reference means having predetermined physical characteristics which are detectable after staining; and one or more containers of stain material, the stain application to the specimen cell objects and the reference means, the stain in the containers being in an effective amount to provide an optical density to the reference means after simultaneous staining of the reference means and specimen cell objects so that after the staining, the optical density of the reference means may be compared with an optical density of the specimen cell objects for the quantitation of cell nuclei in the specimen cell objects.

Claim 9

A kit as recited in claim 6 wherein the stain is selected from the group consisting of thionin, Azure A, Azure C, congo red, pararosanilin, acriflavine, diaminobenzidine, alkaline phosphatase, eosin, methyl green, ethyl green, fast green, methylene blue, hematoxylin, acridine orange, giemsa and mixtures thereof.

Claim 10

A kit as recited in claims 6 or 7 wherein the reference means includes a reference material which is selected from the group consisting of rat liver nuclei, trout erythrocytes, chicken erythrocytes, dried DNA, cultured cell lines and mixtures thereof.

Claim 11

A kit as recited in claim 6 wherein the stain material stains cell objects from human breast cells to provide a kit for breast cancer analysis.

Claim 12

A kit as recited in claims 6 or 7 wherein the kit further includes a stain sulfonating agent.

Claim 13

A kit as recited in claim 8 wherein the kit further includes a stain sulfonating agent.

Claim 14

A kit for use in breast cell analysis by light microscopy, the kit comprising: a microscopic slide, the slide including a reference area and a specimen cell object area for receipt of specimen cell objects, the reference area containing a reference means for staining, the reference means having physical characteristics which permit the reference means to associate with a stain proportionally to an association of the stain with nuclear materials; one or more containers of stain material, the stain material including a stain for simultaneous stain application to the specimen cell objects and the reference means, the stain in the containers selected from the group consisting of methylene blue, methyl green, hematoxylin, fast green, acridine orange and mixtures thereof, the stain in an effective amount and simultaneous staining time in an effective amount to provide the reference means and the specimen cell objects with optical densities for comparison with the other.

Claim 15

A kit for use in breast cell analysis by light microscopy, the kit comprising: a microscopic slide, the slide including a reference area and a specimen cell object area for receipt of specimen cell objects, the reference area containing a reference means for staining, the reference means having physical characteristics which permit the reference means to associate with a stain proportionally to an association of the stain with nuclear materials; one or more containers of stain material, the stain material including a stain for simultaneous stain application to the specimen cell objects and the reference means, the stain in the containers selected from the group consisting of methylene blue, methyl green, hematoxylin, fast green, acridine orange and mixtures thereof, the stain in an effective amount and simultaneous staining time in an effective amount to provide the reference means and the specimen cell objects with optical densities for comparison with the other.

Claim 16

A kit as recited in claim 12 further comprising a rinse sulfonating agent.

Claim 17

A kit as recited in claim 13 wherein the stain is methyl green.

Claim 18

A kit as recited in claim 14 wherein the stain material further includes a stain sulfonating agent.