# US 2019/0170760 A1 · Diagnostic method for pediatric acute-onset neuropsychiatric syndrome (pans) and pediatric autoimmune neuropsychiatric disorder associated with streptococci infection (pandas)

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- Number: US 2019/0170760 A1
- Document ID: US20190170760A1
- Status: Published application
- Kind: A1
- Application number: 16/259,062
- Filed: 2019-01-28
- Published: 2019-06-06
- Earliest claimed: 2013-03-15
- Assignees: Moleculera Labs, Inc.; The Board of Regents of the University of Oklahoma; The United States of America, as represented by the Secretary, Department of Health and Human Serv
- Applicants: Moleculera Labs, Inc.; The Board of Regents of the University of Oklahoma; The United States of America, As Represented by the Secretary, Department of Health and Human Serv
- Inventors: Phina Madeleine Cunningham; Craig David Shimasaki; Susan E. Swedo; Christine Kirvan
- Web page: https://patentgrep.com/patent/US20190170760A1

## CPC

- G01N 33/686: {Anti-idiotype}
- G01N 33/564: for pre-existing immune complex or autoimmune disease {, i.e. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, rheumatoid factors or complement components C1-C9}
- G01N 33/56944: {Streptococcus}
- G01N 33/6854: {Immunoglobulins}
- G01N 33/6896: {Neurological disorders, e.g. Alzheimer's disease}
- G01N 2333/315: from Streptococcus (G), e.g. Enterococci
- G01N 2333/726: G protein coupled receptor, e.g. TSHR-thyrotropin-receptor, LH/hCG receptor, FSH
- G01N 2333/912: transferring phosphorus containing groups, e.g. kinases (2.7)
- G01N 2405/10: Glycosphingolipids, e.g. cerebrosides, gangliosides
- G01N 2469/20: Detection of antibodies in sample from host which are directed against antigens from microorganisms
- G01N 2800/26: Infectious diseases, e.g. generalised sepsis
- G01N 2800/28: Neurological disorders
- G01N 2800/30: Psychoses; Psychiatry
- G01N 2800/38: Pediatrics
- 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)

## Abstract

The present invention provides a panel of at least five clinical analyses or tests (using serum samples) to determine the risk of pediatric acute-onset neuropsychiatric syndrome (PANS) and/or pediatric autoimmune neuropsychiatric disorder associated with streptococcal infection (PANDAS) in an individual. These include enzyme linked immunosorbent assays (ELISAs) to measure antibody titers against neuronal antigens present in the brain; the neuronal antigens include lysoganglioside, tubulin, dopamine receptor D1, dopamine receptor D2, serotonin receptor 5HT2A, and serotonin receptor 5HT2C. Antibody titers against at least four of these neuronal antigens are required in the present methods; preferably antibody titers against all of these neuronal antigens are measured. A final assay is used to quantify calcium/calmodulin-dependent protein kinase activity using a neuronal cell line. The results of these analyses or tests are then combined using an algorithm to determine whether a PANS or PANDAS diagnosis is appropriate for the individual. Depending on the diagnosis, an appropriate treatment can be determined.

## Claims

### Claim 1

(canceled)

### Claim 2

A method of analyzing a sample from a patient, comprising:
a) providing a surface comprising a lysoganglioside, tubulin, and at least one of dopamine receptor D1 and dopamine receptor D2, wherein the lysoganglioside, tubulin, and the at least one of dopamine receptor D1 and dopamine receptor D2 are immobilized on the surface;
b) contacting the surface with the sample to form an anti-lysoganglioside antibody/lysoganglioside complex, an anti-tubulin antibody/tubulin complex, and at least one of an anti-dopamine receptor D1 antibody/dopamine receptor D1 complex and an anti-dopamine receptor D2 antibody/dopamine receptor D2 complex; and
c) measuring from the surface an anti-lysoganglioside antibody titer, an anti-tubulin antibody titer, and at least one of an anti-dopamine receptor D1 antibody titer and an anti-dopamine receptor D2 antibody titer.

### Claim 3 (depends on 2)

The method of claim 2, wherein one or more assay plates comprises said surface.

### Claim 4 (depends on 3)

The method of claim 3, wherein the one or more assay plates is one or more microtiter plates.

### Claim 5 (depends on 3)

The method of claim 3, wherein the one or more assay plates each separately comprises one of the lysoganglioside, the tubulin, and the dopamine receptor D1.

### Claim 6 (depends on 3)

The method of claim 3, wherein the one or more assay plates each separately comprises one of the lysoganglioside, the tubulin, and the dopamine receptor D2.

### Claim 7 (depends on 3)

The method of claim 3, wherein the one or more assay plates each separately comprises one of the lysoganglioside, the tubulin, the dopamine receptor D1, and the dopamine receptor D2.

### Claim 8 (depends on 2)

The method of claim 2, wherein the sample is serum obtained from blood.

### Claim 9 (depends on 2)

The method of claim 2, wherein the sample is obtained from cerebrospinal fluid.

### Claim 10 (depends on 2)

The method of claim 2, wherein the lysoganglioside is lysoganglioside GM1.