A method for monitoring fetal and/or preterm infant development and a method to promote normal growth & development of preterm infants, especially in regards to each preterm infant's collective set of immature organs. Monitoring development is accomplished by using VEGF 121 as a biomarker in bodily fluid levels, to determine whether appropriate angiogenic activity is occurring to allow preterm infant or fetal development to proceed normally. The promotion of preterm infant normal development is accomplished by administering to a preterm infant human chorionic gonadotropin (hCG) and/or Luteinizing hormone (LH) and/or Luteinizing hormone releasing hormone (LHRH) in physiological amounts at appropriate intervals to raise and maintain the activation level of the patient's combined hCG/LH receptor activity, or VEGF 121 level, to a level that is normally present in fetuses of the equivalent developmental (gestational) age. By promoting normal development, we prevent onset or progression of disorders associated with premature organs rather than treat disorders associated with the premature organs after they occur.

A method to predict the risk of eczema is provided based on differences in the development of microbiota and its metabolites in healthy infants and infants that develop eczema, and nutritional remedies based on this finding, in the form of lactate utilizing bacteria and fibres stimulating lactate utilizing bacteria.

Provided are methods for diagnosing a disease in a subject with a previous streptococcal infection by determining the presence or absence of one or more autoantibodies in a biological sample from the subject, wherein the one or more autoantibodies recognize an antigen from a protein selected from the group consisting of ELAVL2, ELAVL3, ELAVL4, Nova-1, Nova-2, Cdr1, Cdr2; and Cdr3. The presence of such autoantibodies is indicative of a positive diagosis for a post-streptococcal disease such as PANDAS, post-GABHS glomerulonephritis, rheumatic fever, autism and Syndenham's chorea.

Early detection of lysosomal storage diseases (LSDs) including Mucopolysaccharidosis Type I (MPS I) and Pompe Disease can greatly improve patient outcome as each disease can be fatal once symptoms emerge. Screening for MPS I and Pompe Disease using biological samples including dried blood spots (DBS), buccal swab, peripheral blood mononuclear cells (PBMCs), or white blood cells (WBCs) is described. The disclosed methods and assays provide a robust way to screen newborns for LSDs. The disclosed methods and assays can also allow rapid prediction of whether a patient with LSD will develop an immune response to enzyme replacement therapy (ERT), thus improving treatment for patients with LSDs. The disclosed methods and assays can also further reduce the number of false positives caused by pseudo deficiency cases of LSD, such as MPS I and Pompe Disease.

A kit-of-parts for the flow cytometric detection of pediatric tumor cells, comprising fluorochrome-conjugated antibodies directed against the cell surface markers CD45, CD56, GD2, CD99, CD8, EpCAM, CD4, smCD3, CD19 and CD271, the cytoplasmic marker cyCD3, and the nuclear marker(s) nuMyogenin and/or nuMyoD1, wherein (i) the antibodies against the markers CD99/CD8 are conjugated to the same fluorochrome and representing a first marker pair CD99/CD8; (ii) the antibodies against the markers EpCAM/CD4 are conjugated to the same fluorochrome and representing a second marker pair EpCAM/CD4; (ii) the antibody against CD271 is conjugated to the same fluorochrome as the antibody against either cyCD3 or smCD3 and representing a third marker pair CD271/cyCD3 or CD271/smCD3; wherein between the first, second and third marker pairs the fluorochromes are distinguishable; and wherein the antibodies against the cytoplasmic and the nuclear markers are physically separated from the antibodies against the cell surface markers.

In certain embodiments, the invention stems from the discovery that analysis of population distribution curves of metabolite levels in blood can be used to facilitate predicting risk of autism spectrum disorder (ASD) and/or to differentiate between ASD and non-ASD developmental delay (DD) in a subject. In certain aspects, information from assessment of the presence, absence, and/or direction (upper or lower) of a tail effect in a metabolite distribution curve is utilized to predict risk of ASD and/or to differentiate between ASD and DD.

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 tiers 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.

Methods of diagnosis and methods of treatment and prevention for autism spectrum disorder are provided using decoy antigens to maternal brain-reactive antibodies.

The present invention provides methods to determine whether a patient with a lysosomal storage disorder will benefit from treatment with a specific pharmacological chaperone. The present invention exemplifies an in vitro method for determining ?-galactosidase A responsiveness to a pharmacological chaperone such as 1-deoxygalactonojirimycin in a cell line expressing a mutant from of ?-galactosidase A. The invention also provides a method for diagnosing Fabry disease in patients suspected of having Fabry disease.

The present invention relates to a monoclonal antibody specific to porcine circovirus 2 (PCV2) and a method for diagnosing post-weaning multi-systemic wasting syndrome (PMWS) using the same. More specifically, the present invention relates to monoclonal antibodies C4-1 and C4-8 of scFV-human C fusion recombinant protein, which specifically binds to a decoy epitope of porcine circovirus 2, and to a method for diagnosing post-weaning multi-systemic wasting syndrome using the same. The monoclonal antibody of the present invention makes it possible to determine whether an antibody against PCV2 is a neutralizing antibody by a vaccine antigen or an antibody induced by immune decoy.