Roche Diagnostics Operations, Inc.

Roche Diagnostics Gmbh

F. Hoffmann-la Roche Ag

Josef Roedl

Eloisa Lopez-Calle

Ewelina Hegel

Thomas Fischer

Thorsten Brueckner

Hans-Peter Josel

Christoph Boehm

Juergen Spinke

Sascha Lutz

Thomas Manuel Keller

Georg Kurz

Thomas Dolbinow

Pamela Espindola

Sabrina Adler

Erik Beiersdorf

Domenik Wensorra

Eva Hoess

Norbert Oranth

Benjamin Tiemann

Noah Weiss

Marisa Kirchenbauer

Joerg Kaufmann

Caroline Bylda

A medical system for determining an analyte quantity in a blood sample via a cartridge that spins around a rotational axis. The cartridge may include: a separation chamber that separates blood plasma from the sample; a processing chamber containing a reagent with a specific binding partner which binds to the analyte to form an analyte specific binding partner complex; a first valve structure connecting the separation chamber to the processing chamber; a measurement structure to measure the quantity of the analyte, wherein the measurement structure includes a chromatographic membrane with an immobilized binding partner for direct or indirect binding of the analyte or the analyte specific binding partner complex, and an absorbent structure that is nearer to the axis than the membrane; a second valve structure connecting the processing chamber to the measurement structure; and a fluid chamber filled with a washing buffer and fluidically connected to the measurement structure.

Determining a quantity of an analyte in a blood sample

The disclosure includes a method for determining an analyte in a sample in an interaction assay, including contacting a sample with an interaction modulator, wherein the interaction modulator is Poly-(4-styrenesulfonic acid-co-maleic acid) (PSSM), aminodextran, carboxymethyldextran, Poly-(2-acrylamido-2-methyl-1-propanesulfonic acid (PAMPS), triethylamine, triethanolamine, taurine, or dodecylsulfate. The disclosure includes a method for determining an analyte in an interaction assay, including contacting the sample with an interaction modulator, wherein the interaction modulator is an enhancer of the interaction assay at low analyte concentrations and is a retarder of the interaction assay at high analyte concentrations and wherein the interaction modulator is Poly-(4-styrenesulfonic acid-co-maleic acid) (PSSM) and/or Polyacrylic acid (PAA). The disclosure further relates to a kit having a detection agent specifically detecting an analyte and at least one interaction modulator. Further, the present disclosure relates to devices relating to the methods and kits.

Methods for modulating signal intensity in interaction assays

The present disclosure relates to an in vitro method for releasing analytes from a sample involving contacting the sample with (i) a chaotropic agent, (ii) an organic solvent, (iii) a detergent, and (iv) at least one agent providing bicarbonate ions. The present disclosure further relates to a release agent for releasing analytes from a sample having the aforesaid compounds. Moreover, the present disclosure relates to uses, kits, methods and devices related to the method and the release agent of the present disclosure.

Generic pretreatment reagents for analyte determinations

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.

Stable formulations for immune-modulatory macrolides

A method for determination of the amount of a specific analyte in a sample which may show a prozone effect by photometric assays, wherein the specific analyte is quantified from the change in the optical signal of the reaction mixture after the interaction of the analyte with analyte specific assay reagents. The optical signal is measured simultaneously for the specific analyte in the sample to be determined at the wavelength used for the determination of the analyte and at least at an additional specific wavelength used for the detection of the prozone effect over the complete reaction time. The reaction rate ratio R is calculated by using the signals obtained at the wavelength used for the detection of the prozone effect. By comparison of the calculated ratio value R with predetermined limit values it is judged if a prozone effect is present in the sample.

Method for the detection of the prozone effect of photometric assays

A method for determining the amount of a specific analyte by photometric assays, wherein the specific analyte in a sample reacts with an analyte specific reaction partner in a reaction mixture. At least two calibration curves are generated, the first calibration curve recorded at a first wavelength is optimized for low concentrations of the specific analyte thereby maximizing the lower detection limit and, the second calibration curve recorded at a second wavelength is optimized for high concentrations of the specific analyte thereby maximizing the upper detection limit. The optimized lower detection limit and the optimized upper detection limit results in an extended dynamic range.

Sensitivity and the dynamic range of photometric assays by generating multiple calibration

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Mutterstadt, Germany

Josef Roedl