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AssigneeThe Trustees of Columbia University in the City of New York
InventorsRobert E. Canfield, Elmo G. Armstrong, Paul H. Ehrlich, Steven Birken
Estimating the term…
An immunoassay for detecting and measuring hCG in a sample includes an antibody directed to the carboxy terminal portion of the .beta. subunit of hCG and a monoclonal antibody directed to a determinant on hCG at a locus sufficiently remote from the carboxy terminal portion of the .beta. subunit of hCG that both antibodies can simultaneously bind to hCG, wherein at least one of the antibodies is delectable when both are bound to hCG. In a presently preferred embodiment, an immunoassay for hCG or hCB.beta. in urine includes a purified, labeled or detectable serum-derived antibody directed to the carboxy-terminal portion of the .beta. subunit of hCG and a matrix-bound monoclonal antibody directed to a locus on the .beta. subunit sufficiently remote from the carboxy-terminal portion that both antibodies can simultaneously bind to hCG or hCG.beta..
A two-site immunoassay for detecting and measuring an increase in the concentration of hCG in a urine sample from a pregnant woman less than ten days after insemination, wherein the immunoassay is capable of detecting hCG at levels down to about 0.004 ng/ml and exhibits cross reactivity with hLH of about 0.0005%, which comprises obtaining the urine sample from the pregnant woman, adjusting the pH of the urine sample to pH 7.4, contacting the resulting urine sample with both an antibody directed specifically to the carboxyl terminal portion of the .beta. subunit of hCG and a monoclonal antibody directed to a determinant on hCG at a locus sufficiently remote from the carboxy terminal portion of the subunit of hCG that both antibodies can be simultaneously bound to hCG, wherein one of the antibodies is attached to a solid matrix and wherein at least one of the antibodies is detectable when both antibodies are bound to hCG, so as to form a detectable and measurable complex which includes the antibodies and hCG, then detecting and measuring the resulting complex, and thereby detecting and measuring the increase in the concentration of hCG in the urine sample.
A two-site immunoassay for detecting and measuring an increase in the concentration of hCG or hCG.beta. in urine sample from a pregnant woman less than ten days after insemination, wherein the immunoassay is capable of detecting hCG at levels down to about 0.004 ng/ml and exhibits cross-reactivity with hLH of about 0.0005%, which comprises obtaining the urine sample from the pregnant woman, adjusting the pH of the urine sample to pH 7.4, contacting the resulting urine sample with both an essentially to the carboxyl terminal portion of the .beta. subunit of hCG and a monoclonal antibody directed to a determinant on hCG or hCG.beta. at a focus on the .beta. subunit of hCG sufficiently remote from the carboxyl terminal portion of the .beta. subunit that both antibodies can be simultaneously bound to hCG, wherein the essentially purified, serum-derived antibody is detectable when both antibodies are bound to hCG or hCG.beta. and wherein the monoclonal antibody is attached to a solid matrix, so as to form a detectable and measurable complex which includes the antibodies and hCG or hCG.beta. , then detecting and measuring the resulting complex, and thereby detecting and measuring the increase in the concentration of hCG in the urine sample.
Dependencies are inferred from the claim text.