This invention relates to diagnostic medical instruments and procedures, and more particularly to implantable devices and methods for monitoring physiological parameters. A device for providing in vivo diagnostics of infections in orthopedic implants having at least one signal processing device operatively coupled with sensors. The signal processing device is operable to receive the output signal from the sensors and transmit a signal corresponding with the output signal. The invention also relates to a method using the device of the invention for detecting infection associated with implants in a human or animal subject.

The present invention relates both to a new reference material based on a blood matrix for use in diagnostics or in-vitro diagnostics, in particular those using sequencing methods of nucleic acids, such as polymerase chain reaction (PCR) or next generation sequencing (NGS), and to a method for its production including validation, in particular a non-invasive liquid biopsy (liquid biopsies).

The present invention relates to a standard cell suspension for confirming the stainability of a treatment solution that differentially stains circulating tumor cells (CTCs) and leucocytes, containing (a) a cell line having an antigen that is specific for human cancer cells and (b) a cell line having an antigen that is specific for human leukocytes, wherein the (a) and (b) components are each a cell line that is fixed by a cell-fixing reagent.

The subject invention pertains to compositions of novel analogs of red blood cells that are distinguishable from white blood cells in a hematological instrument and processes for manufacturing such analogs. The processes for creating the compositions include washing, shrinking, and fixing cells at temperatures at or below room temperature.

A method for the preparation of a cardiac troponin quality control sample of a mammal to determine the accuracy and/or precision of a cardiac troponin assay over time is provided. The method comprises the steps of: i) preparing a cardiac troponin concentrate from a pool of biological samples obtained from a population of the mammal having a troponin concentration of greater than 75% of an upper analytical limit of the assay; ii) obtaining a cardiac troponin base material comprising whole blood, plasma or serum of the mammal which is interference-free and disease-free; and iii) combining a quantity of the troponin concentrate with the base material to yield a quality control sample having a target concentration. Quality control samples may be provided in kits which provide a set of samples having particular concentrations which essentially correspond with lower detectable limits of an assay, upper limits of normal, as well as concentrations which define risk stratification cutoffs and other diagnostic cutoffs.

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.

Disclosed herein are embodiments of a method for calibrating a group of analyzer units, each analyzer unit of the group of analyzer units configured for determining an amount of an analyte in plasma of a whole-blood sample. The method comprises: providing a plurality of calibration whole-blood samples, the plurality of calibration whole-blood samples including calibration whole-blood samples having respective hematocrit levels, for each calibration whole-blood sample of the plurality of calibration whole-blood samples: measuring a hematocrit measurement value indicative of the hematocrit level of said calibration whole-blood sample, measuring a whole-blood measurement value indicative of an amount of the analyte in the calibration whole-blood sample using at least one calibration analyzer unit of said group of analyzer units, measuring a plasma measurement value indicative of an amount of the analyte in plasma of said calibration whole-blood sample, and computing a ratio between the whole-blood measurement value and the plasma measurement value; generating a nonlinear functional relationship between the computed ratios and the corresponding hematocrit measurement values by curve fitting of a nonlinear function parametrized by one or more calibration parameters, the curve fitting resulting in respective parameter values of the one or more calibration parameters; storing a representation of the fitted nonlinear function in each analyzer unit of the group of analyzer units to allow each analyzer unit of the group of analyzer units to compute a hematocrit correction factor.

A method of generating smear quality control information according to an embodiment may include: obtaining a plurality of image data from a plurality of smears, respectively; obtaining, from the plurality of image data, feature values each of which reflects a staining state of each smear; and generating quality control information based on the feature values.

The preparation and use of systems to provide surrogate whole blood controls using coagulation modifiers to simulate human whole blood in coagulation assays are disclosed.

A method of generating smear quality control information according to an embodiment may include: obtaining a plurality of image data from a plurality of smears, respectively; obtaining, from the plurality of image data, feature values each of which reflects a staining state of each smear; and generating quality control information based on the feature values.