Solid-phase analytical device and method for using same
First Claim
1. A solid-phase assay device for use in a binding assay to determine the presence or amount of a specific binding analyte in a fluid sample, comprising a reaction site having:
- a first control area including means for displaying a first detectable response if the assay results are invalid,a second control area including means for displaying a second detectable response indicative of a valid assay result, andan analyte binding area including means for displaying a third detectable response in the presence of label indicative of the presence or amount of the analyte in the fluid sample,substantially oriented in a single area so that each of the first control area, second control area and analyte binding area is capable of being substantially simultaneously contacted by the fluid sample and by reagents used in the assay without the need for performing a separate control assay,wherein said second and third detectable responses, when present, are separately distinguishable and together form an interactive symbol.
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Accused Products
Abstract
A novel material and device useful in solid-phase binding assays to determine the presence or amount of an analyte in a test sample, particularly antigens, antibodies, or other ligands or DNA segments. The material and device comprises a reaction site having procedural controls and an analyte binding area capable of being simultaneously contacted by the sample and reagent used in the performance of the assay. The procedural controls and analyte binding areas operate to provide readable results as to the presence or absence of analyte and simultaneously verify the assay procedure and therefore the assay result.
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Citations
29 Claims
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1. A solid-phase assay device for use in a binding assay to determine the presence or amount of a specific binding analyte in a fluid sample, comprising a reaction site having:
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a first control area including means for displaying a first detectable response if the assay results are invalid, a second control area including means for displaying a second detectable response indicative of a valid assay result, and an analyte binding area including means for displaying a third detectable response in the presence of label indicative of the presence or amount of the analyte in the fluid sample, substantially oriented in a single area so that each of the first control area, second control area and analyte binding area is capable of being substantially simultaneously contacted by the fluid sample and by reagents used in the assay without the need for performing a separate control assay, wherein said second and third detectable responses, when present, are separately distinguishable and together form an interactive symbol. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A solid-phase assay device for use in a binding assay to determine the presence or amount of a specific binding analyte in a fluid sample, comprising:
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a reaction site having a first control area, a second control area, and an analyte binding area, the areas being oriented in the reaction site such that each of the first control area, second control area and analyte binding area is capable of being contacted by the fluid sample and by a reagent capable of producing a detectable response, without the need for performing a separate control assay; wherein, a) said first control area contains means for displaying, upon addition of sample and a reagent capable of producing a detectable response, a first response indicative of an invalid result;
b) said second control area contains means for displaying, upon addition of sample and a reagent capable of producing a detectable response, a second response indicative of a valid result; and
c) said analyte binding area contains means for displaying, upon addition of sample and a reagent capable of producing a detectable response, a third response indicative of the presence or amount of analyte in the sample; andwherein said second and third detectable responses, when present, are separately distinguishable and together form an interactive symbol. - View Dependent Claims (9, 10, 11, 12, 13)
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14. A method for determining the presence of a specific binding analyte in a fluid sample, said method employing a solid-phase assay device comprising:
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a reaction site having a first control area, a second control area, and an analyte binding area, the areas being oriented in the reaction site such that each of the first control area, second control area and analyte binding area is capable of being contacted by the fluid sample and by a reagent capable of producing a detectable response without the need for performing a separate control assay; wherein, a) said first control area contains means for displaying, upon addition of sample and a reagent capable of producing a detectable response, a first response indicative of an invalid result;
b) said second control area contains means for displaying, upon addition of sample and a reagent capable of producing a detectable response, a second response indicative of a valid result; and
c) said analyte binding area contains means for binding analyte, thereby displaying, upon addition of sample and a reagent reactive with analyte and capable of producing a detectable response, a third response indicative of the presence of analyte in the sample; andwherein said second and third detectable responses, when present, are separately distinguishable and together form an interactive symbol; said method comprising; contacting each of said first control area, second control area and analyte binding area with a single application of fluid sample and with a reagent reactive with analyte and capable of producing a detectable response; and examining said reaction site for said first, second and third responses, wherein the absence of said first and third responses together with the presence of said second response indicates a valid determination of no presence of the analyte; and
the absence of said first response together with the presence of said second and third responses indicates a valid determination of the presence of said analyte. - View Dependent Claims (15, 16, 17, 18, 19)
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20. A solid-phase assay device for use in a binding assay to determine the presence or amount of a specific binding analyte in a fluid sample, comprising:
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a reaction site having a first control area, a second control area, and an analyte binding area, the areas being oriented in the reaction site such that each of the first control area, second control area and analyte binding area is capable of being contacted by the fluid sample and by a reagent capable of producing a detectable response, without the need for performing a separate control assay; wherein, a) said first control area contains means for displaying, upon addition of sample and a reagent capable of producing a detectable response, a first response indicative of an invalid result;
b) said second control area contains means for displaying, upon addition of sample and a reagent capable of producing a detectable response, a second response indicative of a valid result; and
c) said analyte binding area contains means for displaying, upon addition of sample and a reagent capable of producing a detectable response, a third response indicative of the presence or amount of analyte in the sample; andwherein said second control area and said analyte binding area are oriented substantially adjacent one another so that said second and third detectable responses, when present, form an interactive symbol which is substantially contiguous. - View Dependent Claims (21, 22, 23, 24)
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25. A method for determining the presence of a specific binding analyte in a fluid sample, said method employing a solid-phase assay device comprising:
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a reaction site having a first control area, a second control area, and an analyte binding area, the areas being oriented in the reaction site such that each of the first control area, second control area and analyte binding area is capable of being contacted by the fluid sample and by a reagent capable of producing a detectable response without the need for performing a separate control assay; wherein, a) said first control area contains means for displaying, upon addition of sample and a reagent capable of producing a detectable response, a first response indicative of an invalid result;
b) said second control area contains means for displaying, upon addition of sample and a reagent capable of producing a detectable response, a second response indicative of a valid result; and
c) said analyte binding area contains means for binding analyte, thereby displaying, upon addition of sample and a reagent reactive with analyte and capable of producing a detectable response, a third response indicative of the presence of analyte in the sample; andwherein said second control area and said analyte binding area are oriented substantially adjacent one another so that said second and third detectable responses, when present, form an interactive symbol which is substantially contiguous; said method comprising; contacting each of said first control area, second control area and analyte binding area with a single application of fluid sample and with a reagent reactive with analyte and capable of producing a detectable response; and examining said reaction site for said first, second and third responses, wherein the absence of said first and third responses together with the presence of said second response indicates a valid determination of no presence of the analyte; and
the absence of said first response together with the presence of said second and third responses indicates a valid determination of the presence of said analyte. - View Dependent Claims (26, 27, 28, 29)
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Specification