Roche Diagnostics Operations, Inc.

Roche Diagnostics Gmbh

F. Hoffmann-la Roche Ag

Benjamin Tiemann

Stefan Quint

Florian Schweinberger

Noah Weiss

Hans-Peter Josel

Uwe Kobold

Eloisa Lopez-Calle

Josef Roedl

Ralf Zimmermann

Ewelina Hegel

Roland Thiele

Marius Wagner

Martin Stingl

Marian Roetzer

Marc Kaminski

Mark Kaminski

A method for multiple transition monitoring of at least one analyte in a sample using a quadrupole mass analyzer is provided and comprises at least one voltage application step, wherein a direct current (DC) voltage and a radio frequency (AC) voltage are applied between two pairs of electrodes of at least one mass filter of the analyzer, wherein the AC voltage has an amplitude Vand the DC voltage has an applicable voltage V, wherein a supplementary AC voltage is superimposed on top of the AC and the DC voltage, wherein an amplitude ΔVof the supplementary AC voltage is wherein Vis a maximum voltage output of the DC voltage and b is a bit size of at least one electronics board of the mass filter of the analyzer; and wherein at least one transition of the analyte is determined with at least one detector of the analyzer.

Method and device for multiple transition monitoring

A method of monitoring a state of a liquid chromatography (LC) stream of an automated analyzer is provided including automatically monitoring a system pressure of an injection assembly of the liquid chromatography stream to generate a time series of system pressures, classifying the time series in one of two or more predetermined classes indicating different states of the LC stream and triggering a response based on the classification result.

Techniques for checking state of analyzers

A liquid chromatography-mass spectrometry (LC-MS) apparatus including an ionization source coupled to a mass spectrometer and a liquid chromatographic (LC) system coupled to the ionization source. The LC system comprises multiple fluidic streams alternately connectable to the ionization source, thereby assigning a detection time window to each fluidic stream from the multiple fluidic streams when connected to the ionization source. The LC-MS apparatus further comprises a controller configured to carry out steps of monitoring an ionization current of the ionization source for the multiple fluidic streams and identifying differences in flow conditions between the multiple fluidic streams based on the monitored ionization current. The controller is further configured to carry out adjusting detection conditions of one or more of the multiple fluidic streams responsive to the identified differences, thereby enabling eluates of interest from each fluidic stream to be detected by the mass spectrometer in the respective detection time window.

Liquid chromatography—stream equivalence by single stream calibration

An analytical system including a mass spectrometer (MS) coupled to liquid chromatography (LC) via an ionization source (IS), and an automated method of maintaining the analytical system in a QC-compliant status are described. The method comprises determining a deviation of the analytical system from a QC-compliant status by determining a deviation of one or more predetermined parameters in an m/z spectrum above one or more predetermined thresholds, triggering an IS and/or MS maintenance procedure upon determining a deviation from the QC-compliant status, determining a return or a failed return to the QC-compliant status during and/or after the IS and/or MS maintenance procedure by determining a return or a failed return respectively of the one or more predetermined parameters in an m/z spectrum below the one or more predetermined thresholds, triggering another IS and/or MS maintenance procedure upon determining a failed return to the QC-compliant status.

Automated method for maintaining a clinical diagnostics system

An automated method of monitoring a state of an analyzer is provided including a mass spectrometer (MS) with an electrospray ionization (ESI) source coupled to a liquid chromatography (LC) stream, including monitoring an electrospray ionization current of the ESI source and identifying a condition of multiple conditions of the analyzer based on the monitored ionization current of the ESI source, one of the conditions being a presence of a dead volume in a liquid chromatography stream of the analyzer downstream of an LC column of the LC stream.

A method and an apparatus for determining a concentration of a target analyte in a sample of bodily fluid are disclosed. The method involves providing a sample of bodily fluid including the target analyte, providing an internal standard solution including a mixture of components having a plurality of isotopes of the target analyte, wherein a concentration of each isotope is unknown, adding the internal standard solution to the sample, analyzing the sample including the internal standard solution using a mass spectrometer, creating a sample function curve based on signal intensities, wherein the signal intensities define arbitrary units, transferring an analyte signal into a corresponding arbitrary analyte unit by means of the sample function curve, and transferring the arbitrary analyte unit into the concentration of a target analyte by means of a standardization function representing a curve of concentrations depending on the arbitrary units.

Method for determining a concentration of a target analyte in a sample of bodily fluid

The present description relates to a liquid composition having at least one immune-modulatory macrolide compound and an essentially cell-free blood hemolysate. The present description further relates to a method for manufacturing a stabilized immune-modulatory macrolide calibration solution, by a) preparing a solution comprising an essentially cell-free blood hemolysate, b) admixing a predetermined amount of at least one immune-modulatory macrolide into said solution comprising an essentially cell-free blood hemolysate, and, thereby c) manufacturing a stabilized immune-modulatory macrolide calibration solution. Furthermore, the present description relates to kits, uses, devices, methods and to an immune-modulatory macrolide compound calibration solution related thereto.

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Munich, Germany

Benjamin Tiemann