How Two Special Antibodies Find Substances in Body Fluids

This patent describes a "sandwich" method using two highly specific, man-made antibodies to detect and measure tiny amounts of specific substances, like disease markers, in a fluid sample.

What it covers

This patent describes a "sandwich" method to find or measure tiny amounts of a specific substance, called an "antigenic substance," in a fluid. First, a sample of the fluid is mixed with a measured amount of a special, man-made "first monoclonal antibody" that has a label, like a radioactive tag (Claim 1(a), Claim 8). This first antibody attaches to the target substance. Then, this mixture is exposed to a "second monoclonal antibody" that is stuck to a solid surface (Claim 1(b)). This second antibody also attaches to the target substance, creating a "sandwich" where the target substance is held between the two antibodies. The solid surface is then separated and washed (Claim 1(c), Claim 5), and the amount of labeled first antibody stuck to it is measured (Claim 1(d)). By comparing this measurement to known samples, the presence or amount of the target substance can be determined (Claim 1(e)). For example, this could be used to detect hepatitis B proteins in a blood sample.

What it doesn't cover

• —Does not cover assays that use polyclonal antibodies, which are mixtures of different antibodies.
• —Does not cover single-antibody detection methods or competitive binding assays.
• —Does not cover methods where both antibodies are soluble or both are bound to a solid surface.
• —Does not cover antibodies with an affinity lower than 10^8 liters/mole for the target substance.

The clever bit

The clever bit was combining the newly available, highly specific "monoclonal antibodies" with the "two-site sandwich" assay format. This allowed for much more precise and reliable detection of tiny amounts of specific substances, reducing false positives and improving consistency compared to older methods using less specific antibody mixtures.

Why it matters

This patent was filed early in the development of monoclonal antibody technology, applying these highly specific tools to the widely used "sandwich" immunoassay format. This combination significantly improved the accuracy and sensitivity of diagnostic tests for various substances in biological fluids. It laid a foundation for more precise detection of disease markers, hormones, and other critical molecules in clinical diagnostics.

Real-world examples

• 1.Home pregnancy tests
• 2.Rapid strep throat tests
• 3.Tests for specific cancer markers like CEA or alphafetoprotein
• 4.Blood tests for hepatitis B
• 5.Tests for thyroid stimulating hormone (TSH) levels