Quantity control device for microscope slide staining assays
First Claim
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1. A quality control device for assessing reagents used in an assay and an assay process, comprising:
- a) a substrate;
b) a first control compound as a target of a first reagent of said assay, immobilized on a first plurality of spatially defined sites on said substrate, and each of said plurality of spatially defined sites having a different amount of said first control compound, said first control compound being an analyte to be detected in said assay, or an analog of said analyte;
c) a second control compound as a target of a second reagent of said assay, immobilized on a second plurality of spatially defined sites on said substrate, and each of said second plurality of spatially defined sites having a different amount of said second control compound;
said second control compound comprising a target of a secondary antibody, an antigenic site different from said analyte or said analog of said analyte, an immunogenic fluorescent molecule, or a chemical used in a first step of a histochemical staining or chromogenic staining; and
d) a third control compound as a target of a third reagent of said assay, immobilized on a third plurality of spatially defined sites on said substrate, each of said third plurality of spatially defined sites having a different amount of said third control compound;
said third control compound comprising a ligand comprising biotin, avidin, streptavidin, or an analog thereof, or a chemical used in a second step of a histochemical staining or chromogenic staining.
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Abstract
A quality control device for microscope slide staining assays and method of use are provided for assessment of the quality of reagents and the assay process of immunohistochemical, in situ hybridization, histochemical, and chromogenic assays. The quality control device includes multiple control compounds, each is immobilized on a plurality of spatially defined sites on a substrate, and each of the plurality of spatially defined sites has a different amount of the control compound. Each of the control compounds is a target of a specific reagent used in the assay.
40 Citations
20 Claims
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1. A quality control device for assessing reagents used in an assay and an assay process, comprising:
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a) a substrate;
b) a first control compound as a target of a first reagent of said assay, immobilized on a first plurality of spatially defined sites on said substrate, and each of said plurality of spatially defined sites having a different amount of said first control compound, said first control compound being an analyte to be detected in said assay, or an analog of said analyte;
c) a second control compound as a target of a second reagent of said assay, immobilized on a second plurality of spatially defined sites on said substrate, and each of said second plurality of spatially defined sites having a different amount of said second control compound;
said second control compound comprising a target of a secondary antibody, an antigenic site different from said analyte or said analog of said analyte, an immunogenic fluorescent molecule, or a chemical used in a first step of a histochemical staining or chromogenic staining; and
d) a third control compound as a target of a third reagent of said assay, immobilized on a third plurality of spatially defined sites on said substrate, each of said third plurality of spatially defined sites having a different amount of said third control compound;
said third control compound comprising a ligand comprising biotin, avidin, streptavidin, or an analog thereof, or a chemical used in a second step of a histochemical staining or chromogenic staining. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 13, 17)
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11. A quality control device for assessing reagents used in an assay and an assay process, comprising:
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a) a substrate;
b) a first control compound as a target of a second reagent of said assay, immobilized on a first plurality of spatially defined sites on said substrate, and each of said plurality of spatially defined sites having a different amount of said first control compound, said first control compound comprising a target of a secondary antibody, an antigenic site different from said analyte or said analog of said analyte, an immunogenic fluorescent molecule, or a chemical used in a first step of a histochemical staining or chromogenic staining; and
c) a second control compound as a target of a third reagent of said assay, immobilized on a second plurality of spatially defined sites on said substrate, and each of said second plurality of spatially defined sites having a different amount of said second control compound;
said second control compound comprising a ligand comprising biotin, avidin, streptavidin, or an analog thereof, or a chemical used in a second step of a histochemical staining or chromogenic staining. - View Dependent Claims (14, 15, 16, 18, 19)
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20. A method of assessment of a reagent and process of an assay comprising:
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(a) providing a control device comprising a first control compound as a target of a second reagent of said assay, immobilized on a first plurality of spatially defined sites on said substrate, and each of said plurality of spatially defined sites having a different amount of said first control compound, said first control compound comprising a target of a secondary antibody, an antigenic site different from said analyte or said analog of said analyte, an immunogenic fluorescent molecule, or a chemical used in a first step of a histochemical staining or chromogenic staining; and
a second control compound as a target of a third reagent of said assay, immobilized on a second plurality of spatially defined sites on said substrate, and each of said second plurality of spatially defined sites having a different amount of said second control compound;
said second control compound comprising a ligand comprising biotin, avidin, streptavidin, or an analog thereof, or a chemical used in a second step of a histochemical staining or chromogenic staining;
(b) contacting said reagents with said substrate; and
(c) assessing reaction of said reagents with said control compounds on said plurality of spatially defined sites on said substrate.
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Specification