Methods for detecting and measuring aggregation
AssigneeTheranos IP Company, LLC
InventorsPaul Patel, Samartha Anekal, Ian Gibbons, Elizabeth A. Holmes, Swapna Joshi
Life of this patent
Estimating the term…
Abstract
Methods, compositions, systems, and devices are provided for performing and analyzing agglutination assays. In one aspect, methods for image analysis of agglutination assays are provided. In another aspects, methods for performing agglutination assays are provided. In one aspect, the methods may be used for the detection of various molecules, including viruses or antibodies against a virus. In another aspect, the methods can be used to determine effective immunization of a subject.
Claims28
1-55. (canceled)
A method for determining the presence of an antibody in a biological sample, where said antibody binds selectively to an agglutinating particle, the method comprising:
- (a) incubating a mixture of visualization particles, the agglutinating particle, and the biological sample suspected of containing said antibody, under conditions permitting agglutination of the visualization particle via interaction with said agglutinating particle;
- and
- (b) capturing with the aid of an optical device an image of said mixture, wherein the presence of a visualization particle-agglutinating particle cluster in said image indicates the occurrence of said agglutination and lack of detectable amount of said antibody, and wherein the absence of said cluster indicates the lack of said agglutination and the presence of detectable amount of said antibody
(canceled)
(canceled)
A method for determining the presence of an agglutinating particle in a biological sample, comprising:
- (a) incubating a mixture of visualization particles and a biological sample suspected of containing said agglutinating particle, under conditions permitting agglutination of the visualization particle via interaction with said agglutinating particle;
- and
- (b) capturing with the aid of an optical device an image of said mixture, wherein the presence of a visualization particle-agglutinating particle cluster in said image indicates the occurrence of said agglutination and the presence of detectable amount of said agglutinating particle, and wherein the absence of said cluster indicates the lack of said agglutination and the lack of detectable amount of said agglutinating particle.
(canceled)
A method for determining the effective immunization of a subject, comprising:
- (a) obtaining a biological sample from a subject that has been immunized with a first dosage of a first vaccine against an agglutinating particle;
- (b) incubating a mixture of visualization particles, said agglutinating particle, and said biological sample, under conditions permitting agglutination of the visualization particles via interaction with said agglutinating particle;
- (c) capturing with the aid of an optical device an image of said mixture;
- and
- (d) determining the concentration of an antibody against said agglutinating particle in said biological sample based on the clusters formed by the agglutination of the visualization particles,
- wherein the presence of a visualization particle-agglutinating particle cluster in said image indicates the occurrence of said agglutination and lack of detectable amount of said antibody, and wherein the absence of said cluster indicates the lack of said agglutination and the presence of detectable amount of said antibody.
63-94. (canceled)
97-99. (canceled)
The method of claim 80, wherein the agglutination is evidenced by the formation of clusters comprising visualization particles and agglutinating particles, and the step of analyzing the image comprises identifying clusters in the image.
The method of claim 80, wherein the step of analyzing the image comprises determining the center-to-center distance between a first visualization particle and a second visualization particle in the image.
107-108. (canceled)
116-117. (canceled)
Dependencies are inferred from the claim text.