Compositions, methods, and systems for detecting immune response
AssigneeCovid Diagnostics Ltd.
InventorColin George Ferrett
Life of this patent
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Abstract
Described herein are compositions and methods for detecting immune response to pathogens. Also described herein are methods and systems utilizing the compositions for detecting adaptive immunity.
Claims87
A container for detecting an immune response to a pathogen by a subject, wherein said container comprises an antigen of said pathogen and an anticoagulation agent, and wherein said antigen comprises a specific T cell recognized epitope of said pathogen.
The container of any one of the preceding claims, further comprising a sample obtained from said subject.
The container of any one of the preceding claims, wherein said subject is a human.
The container of any one of the preceding claims for use in incubating whole blood for at least 30 minutes.
The container of any one of the preceding claims for use in incubating whole blood for at least 6 hours.
The container of any one of the preceding claims for use in incubating whole blood for at least 24 hours.
The container of any one of the preceding claims, wherein said antigen is stable for at least 30 days.
The container of any one of the preceding claims, wherein said anticoagulation agent is heparin, citrate, unfractionated heparin, bivalirudin, or hirudin.
The container of any one of the preceding claims, wherein said pathogen is a mammalian pathogen.
The container of any one of the preceding claims, wherein said pathogen is a viral pathogen and said antigen is from a disease causing virus.
The container of any one of the preceding claims, wherein said antigen comprises at least two specific T cell recognized epitopes of said virus.
The container of any one of the preceding claims, wherein said T cell recognition is by a CD4+ T cell.
The container of any one of the preceding claims, wherein said container further comprises a second antigen comprising a second specific T cell recognized epitope of said pathogen.
The container of any one of the preceding claims, wherein said container further comprises one or more of a sugar, an amino acid, and a vitamin.
The container of any one of the preceding claims further comprising an aluminum adjuvant.
A container for detecting an immune response to a SARS-Cov2 virus in a subject, wherein said container comprises:
- (i) lithium heparin,
- (ii) glucose,
- (iii) an aluminum adjuvant,
- and
- (iv) a SARS-Cov2 antigen that comprises the sequence of SEQ ID NO:
- 2,
- wherein said aluminum adjuvant and said SARS-Cov2 antigen are at a ratio of 1:1 to 3:1 by weight,
- wherein weight of said aluminum adjuvant is as measured by weight of aluminum ion.
A kit for detecting an immune response to a virus in a subject comprising the container of any one of the preceding claims and a second container comprising an anticoagulation agent and not said antigen.
A kit for detecting an immune response to a SARS-Cov2 virus by a subject, wherein said kit comprises:
- a) a first container comprising (i) lithium heparin (ii) glucose, (iii) an aluminum adjuvant, and (iv) a SARS-Cov2 antigen that comprises the peptide sequence of SEQ ID NO:
- 2,
- b) a second container comprising lithium heparin, glucose, and not said SARS-Cov2 antigen, wherein said first and second containers are sterile glass or polycarbonate containers, and
- c) a set of primers that comprise a sequence selected from Table 2.
- wherein said aluminum adjuvant and said SARS-Cov2 antigen are at a ratio of 1:1 to 3:1 by weight,
- wherein weight of said aluminum adjuvant is as measured by weight of aluminum ion.
A method for detecting an immune response to a pathogen by a subject, comprising:
- i) incubating a blood sample from said subject in a container comprising an antigen and an anticoagulation agent, wherein said antigen comprises a specific T cell recognized epitope of said pathogen, and
- ii) incubating a second blood sample from said subject in a second container comprising said anticoagulation agent in (i) and not said antigen,
- iii) quantifying an amount of an immune-response analyte in said container and said second container,
- iv) comparing said amount of said immune-response analyte in said container and said second container to determine whether the subject has an immune response to said pathogen.
A method for detecting an immune response to a SARS-Cov2 virus by a subject, comprising:
- i) incubating a whole blood sample from said subject in a container comprising lithium heparin, glucose, an aluminum adjuvant, and a specific SARS-Cov2 antigen for at least 24 hours,
- ii) incubating a second whole blood sample from said subject in a second container comprising lithium heparin, glucose, an aluminum adjuvant, and not a SARS-Cov2 antigen, and
- iii) quantifying an amount of an IFN-gamma mRNA in said container and said second container to determine whether said subject has an immune response to said SARS-Cov2 virus,
- wherein said aluminum adjuvant and said SARS-Cov2 antigen are at a ratio of 1:1 to 3:1 by weight,
- wherein weight of said aluminum adjuvant is as measured by weight of aluminum ion,
- wherein said SARS-Cov2 antigen comprises the peptide sequence of SEQ ID NO:
- 2,
- and wherein said quantifying in (iii) comprises amplifying said IFN-gamma mRNA with loop-mediated isothermal proliferation (LAMP) assay using primers selected from Table 2.
Dependencies are inferred from the claim text.