Detection of secreted aspartyl proteases from Candida species
First Claim
1. A diagnostic test kit for detecting a secreted aspartyl protease protein within a test sample, the diagnostic test kit comprising:
- an assay device comprising a fluidic medium, the fluidic medium defining a detection zone within which is immobilized a receptive material, wherein the detection zone is capable of generating a detection signal that corresponds to the presence or absence of a secreted aspartyl protease protein; and
a detection probe conjugated with a binding member;
wherein the receptive material, the binding member, or both contain a first antibody that is capable of specifically binding to the secreted aspartyl protease protein.
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Abstract
Methods and devices for the detection of proteins secreted by the hyphal growth form of Candida species are disclosed. The disclosed devices may constitute a method for the diagnosis of acute or chronic infections, including candidiasis, caused by microorganisms of the species Candida, such as C. albicans, for example. The devices of the present invention incorporate antibodies specific to secreted aspartyl protease proteins whose expression is upregulated upon the conversion of the Candida species from the commensal to the pathogenic form. The antibodies may be used in assays to allow the diagnosis of candidal infections and disease conditions. Either monoclonal antibodies or polyclonal antibodies may be used, and in the case of the monoclonals, the specific epitopes of the SAP protein may be detected as well as the SAP protein itself.
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Citations
31 Claims
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1. A diagnostic test kit for detecting a secreted aspartyl protease protein within a test sample, the diagnostic test kit comprising:
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an assay device comprising a fluidic medium, the fluidic medium defining a detection zone within which is immobilized a receptive material, wherein the detection zone is capable of generating a detection signal that corresponds to the presence or absence of a secreted aspartyl protease protein; and
a detection probe conjugated with a binding member;
wherein the receptive material, the binding member, or both contain a first antibody that is capable of specifically binding to the secreted aspartyl protease protein. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A diagnostic test kit for detecting a secreted aspartyl protease protein within a test sample, the diagnostic test kit comprising:
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an assay device comprising a porous membrane, the porous membrane defining a detection zone within which is immobilized a first antibody, wherein the detection zone is capable of generating a detection signal that corresponds to the presence or absence of the secreted aspartyl protease protein; and
a detection probe conjugated with a second antibody;
wherein the first antibody and the second antibody are capable of specifically binding to the secreted aspartyl protease protein. - View Dependent Claims (13, 14, 15, 16, 17)
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18. A method for detecting the presence of a secreted aspartyl protease protein within a test sample, said method comprising:
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i) providing an assay device that comprises a fluidic medium, the fluidic medium defining a detection zone within which is immobilized a receptive material, the detection zone being in fluid communication with detection probes conjugated with a binding member, wherein the receptive material, the binding member, or both contain a first antibody that is capable of specifically binding to the secreted aspartyl protease protein;
ii) contacting the assay device with the test sample; and
iii) generating a detection signal within the detection zone that corresponds to the presence or absence of the secreted aspartyl protease protein. - View Dependent Claims (19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31)
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Specification