The invention encompasses methods and test strips for detecting the presence of cerebrospinal fluid (CSF) in a biological sample with a lateral flow device which uses lectin conjugates, anti-antigen conjugates, an immobilized serum line, and an immobilized anti-antigen line.

The present invention provides a method, wherein the method classifies a subject as suffering from dry eye, the method consisting of: a. obtaining demographic data, consisting of the age and gender of the subject; b. obtaining a tear sample from the patient, and determining the level of human serum albumin; c. from the determined level of human serum albumin, assigning a score for the determined amount of human serum albumin; and d. from the assigned score, calculating a cutoff probability score, according to the following equation: $\frac{\exp \left(-0.6491-1.1142*\mathrm{Albumin}\right)}{1+\exp \left(-0.6491-1.1142*\mathrm{Albumin}\right)}$
wherein the subject has dry eye, if the calculated cutoff probability score is from 50% to 60%.

The present invention is the protein of lactoferrin, or an encoding nucleic acid of the same, for use in the diagnosis or prognosis of Alzheimer's disease (AD). The invention is a method of diagnosis or prognosis of AD in a subject, comprising assessing the level of lactoferrin in the saliva or in a saliva sample of said subject and determining whether said level is above or below a value of 7.43 μg/ml, wherein a value below 7.43 μg/ml is indicative of AD or of the prognosis of AD. Another aspect is the protein of lactoferrin, or an encoding nucleic acid of the same, for use in the diagnosis of Parkinson's disease (PD) in a saliva sample of a subject.

The present invention provides a method, wherein the method classifies a subject as suffering from dry eye, the method consisting of: a. obtaining demographic data, consisting of the age and gender of the subject; b. obtaining a tear sample from the patient, and determining the level of human serum albumin; c. from the determined level of human serum albumin, assigning a score for the determined amount of human serum albumin; and d. from the assigned score, calculating a cutoff probability score, according to the following equation:

[00001]$\frac{\exp \left(-0.6491-1.1142*\mathrm{Albumin}\right)}{1+\exp \left(-0.6491-1.1142*\mathrm{Albumin}\right)}$

wherein the subject has dry eye, if the calculated cutoff probability score is from 50% to 60%.

A method of treating pneumonia in a patient is disclosed comprising administering an effective amount of an IL-6 antagonist to a patient identified as having elevated ferritin level. Also disclosed is a method of achieving an improved clinical response in a patient with pneumonia comprising: a. measuring ferritin level in the patient, and b. administering an effective amount of an IL-6 antagonist to the patient identified as having an elevated ferritin level. The improved clinical response achieved includes: no death by Day 28, not mechanically ventilated by Day 28 (wherein the patient was not mechanically ventilated at baseline), better ordinal score at Day 28, and/or reduced time to hospital discharge within 28 days, compared to the clinical response in a patient with pneumonia and ferritin level that is not elevated. Moreover, a method of reducing time to hospital discharge in a patient with pneumonia comprising administering an effective amount of the IL-6 antagonist to the patient is disclosed, wherein the patient prior to treatment: a. is receiving non-invasive ventilation or high flow oxygen, or is intubated and being mechanically ventilated, and b. has been identified as having elevated IL-6 level.

The present invention provides compositions and methods having improved specificity and sensitivity for the pre-operative assessment of ovarian tumors (e.g., symptomatic and asymptomatic adnexal mass) in a variety of subjects (e.g., pre- and post-menopausal women) having a variety of ovarian cancer types (e.g., low malignant potential, intermediate malignant potential, high malignant potential).

The purpose of the present invention is to provide: an artificial bio sensor that is easy to produce and that exhibits superior specificity; and a method for producing same. Nanoparticles according to the present invention for sensing use comprise a molecular imprint polymer having a molecular imprint space for biological matter. The molecular imprint polymer includes a structural unit derived from functional groups including an interaction group with respect to said biological matter and a signaling substance binding group different from said interaction group. The functional groups are present on the surface of the molecular imprint space. The nanoparticles are useful as an artificial biosensor that is easy to produce and exhibits superior specificity.

The object of the present invention is a method of diagnosis of a chronic kidney disease (CKD) or glomerulopathy in a subject, comprising the following steps: (a) determination of the level of at least three or four or five protein markers selected from the group consisting of serum albumin (ALB), alpha-1-antitrypsin (serpinal), alpha-1-acid glycoprotein 1 (ORM1), serotransferrin (TF) and trefoil factor 1 (TFF), wherein said markers also comprise the non-full-length fragments thereof, in a urine sample from said subject and (b) assigning a probability of the subject having or being at a risk of chronic kidney disease or glomerulopathy or not having nor being at a risk thereof based on the results of the assay of step (a), wherein this involves estimating a probability of the subject having or being at a risk of chronic kidney disease or glomerulopathy or not having nor being at a risk thereof based on the level of each of the marker levels determined in (a)), the probability being estimated based on the levels of each of the markers as determined in subjects known to suffer from a glomerulopathy or a chronic kidney disease; and determining the probability of the subject, providing the urine sample tested in step (a), having or being at a risk of a glomerulopathy or a chronic kidney disease or not having nor being at a risk thereof as a product of the corresponding probabilities obtained from each marker. A further object of the present invention is a method of monitoring a response to treatment of a chronic kidney disease (CKD) or glomerulopathy in a subject, comprising the following steps: a) measurement of the level, at a first point in time, for three or four or five of the markers selected from a group consisting of serum albumin (ALB), alpha-1-antitrypsin (serpinal), alpha-1-acid glycoprotein 1 (ORM1), serotransferrin (TF) and trefoil factor 1 (TFF), wherein said markers also comprise the non-full-length fragments thereof, in a urine sample from a subject; b) repeating the assay of step (a) at a later point in time after a period wherein the subject was undergoing a treatment; c) assessing a response to said treatment by comparing the results of the assays of steps (a) and (b), wherein lower marker levels after treatment are indicative of a positive response to treatment. A further object of the present invention is a method of treatment of a chronic kidney disease (CKD) or glomerulopathy in a subject, comprising the following steps: (a) determination of the level of at least three or four or five protein markers selected from the group consisting of serum albumin (ALB), alpha-1-antitrypsin (serpinal), alpha-1-acid glycoprotein 1 (ORM1), serotransferr

The present invention provides methods and systems to accurately detect and measure levels of endogenous antibodies, for examples endogenous IgA, to particular antigens in a biological sample from a companion animal, which is useful to diagnose inflammatory conditions, including bowel disease (IBD), gastrointestinal infections, and food sensitivities in companion animals, e.g., dogs or cats, and to distinguish among such gastrointestinal disorders. Such methods and systems identify whether a sample from the patient is associated with an inflammatory condition, infection, and/or food sensitivity condition, by using non-invasive means, thus conveniently providing information useful for guiding treatment decisions.

In certain aspects, the present invention provides methods for dosing a patient with an ActRIIb antagonist and methods for managing patients treated with an ActRIIb anatagonist. In certain aspects, the methods involve measuring one or more hematologic parameters in a patient.