The invention generally relates to the field of immunoassays. In particular, the invention relates to use of a calibrator material to calibrate immunoassays for autoantibodies.

The present invention provides a test method which enables specific diagnosis of early-stage pathology of diabetic nephropathy. There is provided a method of detecting onset or a risk of onset of diabetic nephropathy, comprising measuring IgG4 in a biological sample derived from a subject. This method may further comprise measuring Smad1 in the biological sample derived from the subject. Preferably, both IgG4 and Smad1 are measured.

The present invention provides novel biomarkers for dementia. Methods for diagnosing dementia or the risk of developing dementia, or for monitoring dementia progression are also provided. The invention also provides methods for determining the therapeutic effect of appropriate treatment regimens or determining a subjects compliance or adherence with a prescribed treatment regimen. A method for monitoring changes in cognition in a subject having or suspected of having dementia is also provided. Corresponding kits, assay devices and uses are also provided.

The application is about a method for diagnosing autism spectrum disorder (ASD) in a human subject, comprising providing a device comprising a reagent for determining the concentration of arginine vasopressin (AVP) in a biological sample from the subject; and measuring the concentration of AVP in the sample using the device. Disclosed is also a method for diagnosing ASD, comprising providing a first device comprising a reagent for determining a concentration of AVP and a second device comprising a reagent for determining a concentration of one or more analytes selected from arginine vasopressin receptor 1a and oxytocin receptor, to determine the concentrations of AVP and of the one or more analytes. Disclosed is also a method of predicting severity of ASD in a male human subject, comprising providing a device for determining the concentration of AVP in cerebrospinal fluid, said device comprising a reagent for determining presence or absence of AVP; and measuring the concentration of AVP in a biological sample from the subject using the device. Disclosed is also a method of predicting likelihood of an ASD in a human subject, comprising providing a device for determining the concentration of AVP in cerebrospinal fluid, said device comprising a reagent for determining presence or absence of AVP; and measuring the concentration of AVP in cerebrospinal fluid using the device.

The present invention has been made in view of a problem regarding stability, reproducibility, economy, and easiness of operation in studies for a monocyte- or dendritic cell-mediated infectious microorganism, and is directed to provide a method for maintenance culturing a monocyte- or dendritic cell-mediated infectious microorganism utilizing a monocyte having a proliferative capacity. The present invention is based on the finding that a dengue virus efficiently infects a proliferable human monocytic cell obtained by introducing a gene into a CD14-positive cell and a cell having a phagocytic capacity obtained by inducing the monocytic cell to differentiate (e.g., dendritic cell) and proliferates therein. Thus, provided is a novel method for evaluating a pharmaceutical such as a compound or a vaccine for treating an infection with a monocyte- or dendritic cell-mediated infectious microorganism.

Reagents are disclosed for use with potentiometric magnesium ion selective electrodes, along with kits containing same as well as methods of use thereof.

The present invention relates to certain volatile organic compounds which can be detected in stool samples of individuals and be used as biomarkers in determining the probability that an individual has colorectal cancer.

The present disclosure relates to assays, including but not limited to, leukocyte adhesive function assays (LAFA), devices and/or methods of using such assays. The present disclosure also relates to the uses of the disclosed embodiment in diagnostic, analytic and/or prognostic applications, particularly for diagnostic, analytic and/or prognostic applications in relation to diseases associated with abnormal host immune responses.

The present invention provides diagnostic methods, therapeutic methods, and compositions for the treatment of cancer (e.g., kidney cancer (e.g., renal cell carcinoma (RCC)). The invention is based, at least in part, on the discovery that expression levels of one or more biomarkers described herein in a sample from an individual having cancer can be used in methods of predicting the therapeutic efficacy of treatment with a VEGF antagonist (e.g., an anti-VEGF antibody, (e.g., bevacizumab) or a VEGFR inhibitor (e.g., a multi-targeted tyrosine kinase inhibitor (e.g., sunitinib, axitinib, pazopanib, or cabozantinib))) and a PD-L1 axis binding antagonist (e.g., a PD-L1 binding antagonist (e.g., anti-PD-L1 antibody, e.g., atezolizumab (MPDL3280A)) or a PD-1 binding antagonist (e.g., anti-PD-1 antibody)), or with an angiogenesis inhibitor (e.g., a VEGF antagonist (e.g., a VEGFR inhibitor, (e.g., a multi-targeted tyrosine kinase inhibitor (e.g., sunitinib, axitinib, pazopanib, or cabozantinib)))).

The subject matter of the invention relates to a method for in vitro diagnosis of Lyme disease and a method for in vitro differential diagnosis of Lyme arthritis versus rheumatoid arthritis, in which methods, in a sample from a subject, the level of lysophosphatidylethanolamine comprising myristic acid (LysoPE(14:0)) is determined and such determined level of lysophosphatidylethanolamine is compared with the level of lysophosphatidylethanolamine comprising myristic acid in a reference sample; in wherein the level of lysophosphatidylethanolamine comprising myristic acid which is higher than the level in the said reference sample indicates that the subject suffers from Lyme disease. The subject matter of the invention further relates to lysophosphatidylethanolamine comprising myristic for use as a biomarker of Lyme disease, as a biomarker of Lyme arthritis, as a biomarker for differential diagnosis of Lyme arthritis versus rheumatoid arthritis, as a biomarker of neuroborreliosis. The subject matter of the invention also relates to a kit for in vitro diagnosis of Lyme disease and a kit for in vitro differential diagnosis of Lyme arthritis, which kits comprise a means for determining the level of lysophosphatidylethanolamine comprising myristic acid and instructions for carrying out the methods for diagnosis according to the invention.