Immunoassays for prostate specific antigen
First Claim
1. An immunoassay method for detecting or quantitating an Analyte ("A") in a sample, the Analyte being capable of existing in the sample in a free form ("free Analyte") or bound to a Binding Molecule to form a complex of the Analyte and the Binding Molecule ("{(A)(Binding Molecule)}"), the method comprising the steps of:
- (a) contacting the Analyte to an antibody ("α
HE") which can bind the free Analyte but not {(A)(Binding Molecule)}, a capture antibody ("α
nHE") which can bind both the free Analyte and {(A)(Binding Molecule)}, and a probe antibody ("α
A*") specific for the Analyte, providing that if the probe antibody is a polyclonal antibody then the Analyte is contacted to the capture antibody before the probe antibody;
(b) correlating the presence or amount of α
A* which is bound to the Analyte, with the presence or amount of the Analyte in the sample, or correlating the amount of unbound α
A* with the absence or amount of the Analyte in the sample.
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Accused Products
Abstract
The present invention relates to the field of cancer immunoassay. Specifically, a new immunoassay method for prostate specific antigen (PSA) is presented. Also presented is a complex which resembles a complex of PSA and α-antichymotrypsin (ACT) that can be used as a calibrator or control in an immunoassay for PSA. Further presented is a method for fractionating polyclonal antibodies, to PSA, into those which bind epitopes that are masked by the binding of PSA to ACT and those which do not bind such epitopes.
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Citations
33 Claims
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1. An immunoassay method for detecting or quantitating an Analyte ("A") in a sample, the Analyte being capable of existing in the sample in a free form ("free Analyte") or bound to a Binding Molecule to form a complex of the Analyte and the Binding Molecule ("{(A)(Binding Molecule)}"), the method comprising the steps of:
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(a) contacting the Analyte to an antibody ("α
HE") which can bind the free Analyte but not {(A)(Binding Molecule)}, a capture antibody ("α
nHE") which can bind both the free Analyte and {(A)(Binding Molecule)}, and a probe antibody ("α
A*") specific for the Analyte, providing that if the probe antibody is a polyclonal antibody then the Analyte is contacted to the capture antibody before the probe antibody;(b) correlating the presence or amount of α
A* which is bound to the Analyte, with the presence or amount of the Analyte in the sample, or correlating the amount of unbound α
A* with the absence or amount of the Analyte in the sample. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22)
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23. A kit for conducting an assay for Analyte in a sample, wherein the Analyte can exist in the sample as a free Analyte or bound to a Binding Molecule to form a complex of Analyte-Binding Molecule Complex, the kit comprising the following:
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(a) a first container containing an antibody (α
HE) specific to the Analyte which can bind to the free Analyte but not Analyte-Binding Molecule Complex;(b) a second container containing a capture antibody specific for the Analyte; and (c) a third container containing a probe antibody specific for the Analyte. - View Dependent Claims (24, 25, 26, 27, 28, 29)
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30. A kit for conducting an assay for Analyte in a sample, wherein the Analyte can exist in the sample as a free Analyte or bound to a Binding Molecule to form a complex of Analyte-Binding Molecule Complex, the kit comprising the following:
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(a) a first container containing; (i) a capture antibody specific for the Analyte, and (ii) an antibody (α
HE) specific to the Analyte which can bind the free Analyte but not the Analyte-Binding Molecule Complex; and(b) a second container containing a probe antibody specific for the Analyte.
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31. A kit for conducting an assay for Analyte in a sample, wherein the Analyte can exist in the sample as a free Analyte or bound to a Binding Molecule to form a complex of Analyte-Binding Molecule Complex, the kit comprising the following:
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(a) a first container containing a capture antibody specific for the Analyte; and (b) a second container containing; (i) an antibody (α
HE) specific to the Analyte which can bind the free Analyte but not the Analyte-Binding Molecule Complex, and(ii) a probe antibody specific for the Analyte.
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32. An immunoassay method for detecting or quantitating an Analyte ("A") in a sample, the Analyte being capable of existing in the sample in a free form ("free Analyte") or bound to a Binding Molecule to form a complex of {(A)(Binding Molecule)}, the method comprising the steps of:
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(a) incubating the sample with polyclonal capture antibodies ("α
A") which contain antibodies which bind the free Analyte and antibodies which bind {(A)(Binding Molecule)};(b) incubating the sample with an antibody α
HE capable of binding free analyte but not {(A) (Binding Molecule)} for a sufficient time for the α
HE to bind to the Analyte;(c) incubating the sample with a probe antibody ("α
nHE*") capable of binding both the free Analyte and {(A)(Binding Molecule)}; and(d) correlating the presence or amount of α
nHE* bound to the Analyte with the presence or amount of Analyte in the sample;
or correlating the amount of unbound α
nHE* with the absence or amount of the Analyte in the sample.
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33. An immunoassay method for defecting or quantitating Analyte ("A") in a sample, the Analyte being capable of existing in the sample in a free form ("free Analyte") or bound to a Binding Molecule to form a complex of {(A)(Binding Molecule)}, the method comprising the steps of:
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(a) incubating the sample with a capture antibody ("α
nHE") which can bind both free Analyte and {(A)(Binding Molecule)}, for a sufficient time for the capture antibody to bind to any Analyte and {(A)(Binding Molecule)} that may be present in the sample to form complexes of {(α
nHE)(A)} and {(α
nHE)(A)(Binding Molecule)}, respectively;(b) incubating the sample with an antibody α
HE which can bind the free Analyte but not {(A) (Binding Molecule)} for a sufficient time for the α
HE to bind to the Analyte;(c) incubating the sample with a probe antibody ("α
A*") specific for the Analyte for a sufficient time to bind to the Analyte;(d) detecting the presence or amounts of the complexes of {(α
nHE)(A)(α
HE)(α
A*)} and {(α
nHE)(A)(Binding Molecule)(α
A*)}, or free α
A*; and(e) correlating the presence or amounts of {(α
nHE)(A)(α
HE)(α
A*)} and {(α
nHE)(A)(Binding Molecule)(α
A*)} with the presence or amount of the Analyte in the sample;
or correlating the amount of free α
A* with the absence or amount of the Analyte in the sample.
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Specification