The present invention provides for a new therapeutic tools capable of treating infectious diseases, in particular, a new pharmaceutical composition comprising an IgM-enriched immunoglobulin preparation for use in the adjunctive treatment of severe Community Acquired Pneumonia (sCAP).

Medical devices and methods thereof for determining bacterial infections in blood. The medical devices and methods thereof can utilize a coating including an antibody conjugated to a reporter protein configured to indicate a bacterial infection in a patient's blood by way of an antigen thereof. Exemplary medical devices include, but are not limited to, a catheter assembly, an AV fistula needle set, an extension set for either a catheter assembly or an AV fistula needle set, and a hemodialysis tubing set. The medical devices and methods thereof can utilize immunochromatographic separation of the antibody and an antigen-antibody complex to indicate a bacterial infection in a patient's blood.

A diagnostic reagent that is suitable for turbidimetric analysis with a simple photometer and has high sensitivity for quantitative determination of procalcitonin in a sample is provided. The reagent is an aqueous suspension of polymer particles with antibodies against procalcitonin covalently bound to said polymer particles, in which no or only an extremely slight tendency to agglutination/sedimentation is detectable even after longer standing times and the specific reactivity of the particles remains largely unchanged. The suspended polymer particles have an average particle size in the range from 150 to 450 nm, the suspension includes a proportion of sugar or sugar alcohol dissolved therein in the range from 25 to 250 g/l and the suspension has a pH in the range from 8 to 10.

Medical devices and methods thereof for determining bacterial infections in blood. The medical devices and methods thereof can utilize a coating including an antibody conjugated to a reporter protein configured to indicate a bacterial infection in a patient's blood by way of an antigen thereof. Exemplary medical devices include, but are not limited to, a catheter assembly, an AV fistula needle set, an extension set for either a catheter assembly or an AV fistula needle set, and a hemodialysis tubing set. The medical devices and methods thereof can utilize immunochromatographic separation of the antibody and an antigen-antibody complex to indicate a bacterial infection in a patient's blood.

A method for predicting sepsis or diagnosing systemic inflammatory response syndrome (SIRS) and/or sepsis in a subject comprises determining levels of at least three markers selected from CCL23, A1AT, CRP, sICAM, PLA2, IL-6, procalcitonin, MMP8, TNFalpha, AcPGP, enzymatic MMP activity, TIMP1, sRAGE and desmosine in a sample taken from the subject. The combined levels of the at least three markers are used to predict or diagnose SIRS and/or sepsis. The methods may be performed on a subject with SIRS and which is used to identify an infection in the subject. A preferred panel of markers includes CCL23, A1AT, sICAM, sICAM/VCAM-1 and CRP. Corresponding products, methods of treatment and medical uses are provided.

The present invention relates to the determination of the level of marker peptides in a sample derived from a bodily fluid of a subject presenting with non-specific complaints.

The precision of a lateral flow assay for determining the concentration of an analyte in the plasma fraction of a sample of whole blood can be significantly improved by applying an integrated step for determining the hematocrit of the optionally diluted sample, and taking both hematocrit and dilution factor into account when calculating the concentration of the analyte. This is made possible inter alia by using a predetermined wavelength when taking an image of the sample after application to a substrate in the lateral flow assay device, and wherein said wavelength is selected based on the dilution factor used. This hematocrit measurement is advantageously integrated in lateral flow assay methods and devices for the measurement of an analyte in plasma and contributes significantly to an improved precision of such assays.

In vitro methods such as in vitro diagnosis, prognosis and risk stratification of a patient having a primary disease, whereby the level of Procalcitonin (PCT) or fragment thereof in a sample of a bodily fluid of the patient is indicative for the risk of the patient to contract a further disease or medical condition. Assays for performing such methods and samples containing complex resulting from such methods.

The present invention concerns methods for the detection f target molecules in a sample including several steps of signal amplification allowing the detection of a very low number of target molecules in the tested sample. The detection assay is based on the use of a universal probe which enables the signal amplification. The specific recognition of the target molecule is achieved by using a specific binding agent, preferably an aptamer. The invention further concerns kits and methods for the diagnosis of pathological conditions.

A diagnostic method for the identification of a subject suffering from a primary non-infectious disease having an increased risk of an adverse outcome potentially being induced by the administration of an antibiotic to said subject comprising the determination of the level of Procalcitonin (PCT) or a fragment thereof or a precursor or fragment thereof having a length of at least 12 amino acid residues in a sample of a bodily fluid from said subject and the correlation of the determined level to a potential risk induced by the administration of an antibiotic, as well as a kit for performing the method and methods of treatment based thereon.