# US 2019/0170751 A1 · Immunoassay methods and compositions for detecting infection involving use of test antigens as cross-reactive control antigens

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- Number: US 2019/0170751 A1
- Document ID: US20190170751A1
- Status: Published application
- Kind: A1
- Application number: 16/321,284
- Filed: 2017-08-01
- Published: 2019-06-06
- Earliest claimed: 2016-08-01
- Assignees: InBios International, Inc.
- Applicants: InBios International, Inc.
- Inventors: James William NEEDHAM; Syamal RAYCHAUDHURI
- Web page: https://patentgrep.com/patent/US20190170751A1

## CPC

- G01N 33/56983: {Viruses}
- C07K 16/116: Togaviridae (F); Matonaviridae (F); Flaviviridae (F)
- C07K 16/4283: {against an allotypic or isotypic determinant on Ig}
- G01N 33/543: with an insoluble carrier for immobilising immunochemicals
- G01N 33/563: involving antibody fragments
- G01N 2333/183: Flaviviridae, e.g. pestivirus, mucosal disease virus, bovine viral diarrhoea virus, classical swine fever virus (hog cholera virus) or border disease virus
- G01N 2469/20: Detection of antibodies in sample from host which are directed against antigens from microorganisms
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

The present invention relates to compositions and methods involving diagnostic tests with multiple test antigens. The present invention involves the expanded use of test antigens as cross-reactive control antigens (CCAs). The invention advantageously provides for enhanced test results analysis by simultaneously providing both test antigen and CCA signal results. These results, in turn, allow useful sample comparison and cross-reference between samples to more accurately identify and verify the fidelity of test results obtained for multiple infective agents at once. The present invention may include compositions and methods for detecting infection by Zika virus or another flavivirus, and may distinguish between infections caused by genetically similar agents.

## Claims

### Claim 1

A diagnostic assay comprising different test antigens, wherein each test antigen binds to each of a common bound component and a common test antigen conjugate.

### Claim 2 (depends on 1)

The diagnostic assay of claim 1, wherein each of the different test antigens indicates the presence of absence of a particular bound component and also indicates the likelihood of cross-reactivity error relative to at least one other different test antigen.

### Claim 3 (depends on 1)

The diagnostic assay of claim 1, wherein the different test antigens share a common genetic heritage or genetic similarity.

### Claim 4 (depends on 3)

The diagnostic assay of claim 3, wherein the different test antigens are derived from members of a shared viral genus selected from the flavivirus genus and the alphavirus genus.

### Claim 5 (depends on 4)

The diagnostic assay of claim 4, wherein the members include two or more viruses selected from Zika virus, dengue virus, and West Nile virus, or derivations thereof.

### Claim 6 (depends on 4)

The diagnostic assay of claim 4, wherein the members include two of more viruses selected from Chikungunya virus, Ross River virus, Semliki Forest virus, Venezuelan equine encephalitis virus, and Western equine encephalitis virus, or derivations thereof.

### Claim 7 (depends on 1)

The diagnostic assay of claim 1, wherein each of the different test antigens is a cross-reactive control.

### Claim 8 (depends on 1)

The diagnostic assay of claim 1, wherein the different test antigens are analyzed substantially simultaneously.

### Claim 9 (depends on 1)

The diagnostic assay of claim 1, wherein at least one different test antigen is a virus-like particle.

### Claim 10 (depends on 1)

The diagnostic assay of claim 1, wherein the common test antigen conjugate also provides a detectable signal.

### Claim 11 (depends on 10)

The diagnostic assay of claim 10, wherein a material used for the detectable signal is the same for the different test antigens.

### Claim 12 (depends on 10)

The diagnostic assay of claim 10, wherein the presence or absence of each different test antigen is indicated by relative signal strength.

### Claim 13 (depends on 1)

the diagnostic assay of claim 1, wherein the bound component is an antibody.

### Claim 14 (depends on 1)

the diagnostic assay of claim 1, wherein the bound component is derived from a test subject sample.

### Claim 15 (depends on 1)

The diagnostic assay of claim 1, wherein all test components and buffers for the different test antigens are substantially the same.

### Claim 16 (depends on 1)

A kit comprising the diagnostic assay of claim 1.

### Claim 17

A method for distinguishing between related infective agents in vitro comprising: at least two different test antigens; and a common cross-reactive test antigen conjugate.

### Claim 18 (depends on 17)

The method of claim 17, further comprising: generating a detectable signal from at least one of the two different test antigens; and using each of the at least two different test antigens as a cross-reactive control antigen.

### Claim 19 (depends on 18)

The method of claim 18, further comprising: establishing a threshold based on detectable signal strength; and distinguishing between the related infective agents based on relative signal strength.

### Claim 20 (depends on 17)

The method of claim 17, further comprising including a test antigen to an unrelated infective agent, wherein the unrelated infective agent produces similar symptoms in a test subject or is an infective agent to which the test subject may have been exposed.

### Claim 21 (depends on 17)

The method of claim 17, further comprising exposing the at least two different test antigens to a common bound component.

### Claim 22 (depends on 17)

The method of claim 17, wherein the related infective agents belong to the flavivirus genus.

### Claim 23 (depends on 17)

The method of claim 17, wherein the related infective agents belong to the alphavirus genus.

### Claim 24 (depends on 22)

The method of claim 22, wherein the related infective agents are selected from the Zika virus, dengue virus, and West Nile virus, or derivations thereof.

### Claim 25 (depends on 23)

The method of claim 23, wherein the related infective agents are selected from the Chikungunya virus, Ross River virus, Semliki Forest virus, Venezuelan equine encephalitis virus, and Western equine encephalitis virus, or derivations thereof.

### Claim 26 (depends on 20)

The method of claim 20, wherein the unrelated infective agent is chikungunya.
