order to form a soluble complex of the antibody and antigenic
substance present in said sample, said first monoclonal antibody being
labeled;
(b) contacting the soluble complex with a second monoclonal
antibody to the antigenic substance, said second monoclonal antibody
being bound to a solid carrier, said solid carrier being insoluble in said
fluid, in order to form an insoluble complex of said first monoclonal
antibody, said antigenic substance and said second monoclonal
antibody bound to said solid carrier;
(c) separating said solid carrier from the fluid sample and
unreacted labeled antibody;
(d) measuring either the amount of labeled antibody associated
with the solid carrier or the amount of unreacted labeled antibody; and
(e) relating the amount of labeled antibody measured with the
amount of labeled antibody measured for a control sample prepared
in accordance with steps (a)-(d), said control sample being known to
be free of said antigenic substance, to determine the presence of
antigenic substance in said fluid sample, or relating the amount of
labeled antibody measured with the amount of labeled antibody
measured for samples containing known amounts of antigenic
substance prepared in accordance with steps (a)-(d) to determine the
concentration of antigenic substance in said fluid sample, the first and
second monoclonal antibodies having an affinity for the antigenic
substance of at least about 10 liters/mole.8
10. A process for the determination of the presence of an antigenic
substance in a fluid comprising the steps:
(a) simultaneously contacting a sample of the fluid with first
and second monoclonal antibodies to said antigenic substance, each
monoclonal antibody having an affinity for the antigenic substance of
at least about 10 liters/mole, said first monoclonal antibody being8
labeled and soluble in said fluid and being provided for in a measured
amount and said second monoclonal antibody being bound to a solid
carrier insoluble in said fluid, in order to form an insoluble complex of
said first monoclonal antibody, said antigenic substance and said
second antibody;
(b) separating said solid carrier from the fluid sample and
unreacted labeled antibody;
(c) measuring either the amount of labeled antibody associated
with the solid carrier or the amount of unreacted labeled antibody; and
(d) relating the amount of labeled antibody measured with the
amount of labeled antibody measured for a control sample prepared
in accordance with steps (a)-(c), said control sample being known to
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