Breast cyst fluid protein assay
First Claim
1. A method for determing the concentration of the glycoprotein gross cystic disease fluid protein-15 (GCDFP-15) in a biological fluid sample which method comprises conducting an immunoassay for said glycoprotein in said sample utilizing as reagents a GCDFP-15 selective antibody and GCDFP-15 labelled with a unique and detectable label to produce an antigen-antibody reaction product, separating said product from the said reagents and determining the concentration of GCDFP-15 in said sample by detecting the quantitative value of said label in either said reaction product or said reagents and comparing said label value to a standard curve wherein said GCDFP-15 is further characterized as follows:
- (a) a glycoprotein having a calculated monomer size of about 15,000 daltons as determined by sodium dodecyl sulfate acrylamide gel analysis; and
(b) immunologically not identical to any components of plasma as determined by Ouchterlony analysis; and
(c) immunological cross identity with a component of human milk and human saliva.
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Abstract
This disclosure relates to assay of a glycoprotein component of human breast gross cystic disease fluid which has been designated GCDFP-15. This material is a useful marker in monitoring the efficacy of therapy in women with metastatic breast carcinoma and also in determining the maturity of the fetus in pregnant women. The assay for GCDFP-15 can also be used in conjunction with other assays for breast carcinoma such as an assay for carcinoembryonic antigen (CEA) whereby the utilization of both tests is more effective in monitoring for recurrence of disease than using either assay alone.
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Citations
12 Claims
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1. A method for determing the concentration of the glycoprotein gross cystic disease fluid protein-15 (GCDFP-15) in a biological fluid sample which method comprises conducting an immunoassay for said glycoprotein in said sample utilizing as reagents a GCDFP-15 selective antibody and GCDFP-15 labelled with a unique and detectable label to produce an antigen-antibody reaction product, separating said product from the said reagents and determining the concentration of GCDFP-15 in said sample by detecting the quantitative value of said label in either said reaction product or said reagents and comparing said label value to a standard curve wherein said GCDFP-15 is further characterized as follows:
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(a) a glycoprotein having a calculated monomer size of about 15,000 daltons as determined by sodium dodecyl sulfate acrylamide gel analysis; and (b) immunologically not identical to any components of plasma as determined by Ouchterlony analysis; and (c) immunological cross identity with a component of human milk and human saliva. - View Dependent Claims (2)
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3. A method useful in detection of metastatic breast carcinoma disease and for monitoring the effectiveness of therapeutic regimens in patients with said metastatic disease which method comprises determining the concentration of the glycoprotein gross cystic disease fluid protein-15 (GCDFP-15) in plasma samples from said patients on at least two separate occasions by conducting an immunoassay for said glycoprotein in each said plasma sample utilizing as reagents a GCDFP-15 selective antibody and GCDFP-15 labelled with a unique and detectable label to produce an antigen-antibody reaction produce, separating said product from the said reagents and determining the concentration of GCDFP-15 in the plasma by detecting the quantitative value of said label in either said reaction product or said reagents and comparing said label value to a standard curve whereby a decrease in the level of the GCDFP-15 in serial plasma samples is indicative of disease regression or stabilization and an increase in the level of the GCDFP-15 in serial plasma samples is indicative of disease progression wherein said GCDFP-15 is further characterized as follows:
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(a) a glycoprotein having a calculated monomer size of about 15,000 daltons as determined by sodium dodecyl sulfate acrylamide gel analysis; and (b) immunologically not identical to any components of plasma as determined by Ouchterlony analysis; and (c) immunological cross identity with a component of human milk and human saliva. - View Dependent Claims (4, 5, 6, 7, 8, 9, 10, 11, 12)
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Specification