Siemens Healthcare Diagnostics Gmbh

Amy Posey

Tie Q Wei

Alan Robert Craig

Christy Schaible

Gerald Siefring

Gerald Siefring, Jr

Methods and reagents are disclosed for pretreating a sample suspected of containing a hydrophobic drug for conducting an assay method for detecting the hydrophobic drug. A combination is provided in a medium that includes the sample, a releasing agent for releasing the hydrophobic drug and the metabolites from endogenous binding moieties, and a selective solubility agent that provides for substantially equal solubility of the hydrophobic drug and the metabolites in the medium. The selective solubility agent includes a water miscible, non-volatile organic solvent and is present in the medium in a concentration sufficient to provide for substantially equal solubility of the hydrophobic drug and the metabolites in the medium. The medium, which may further include a hemolytic agent, is incubated under conditions for releasing the hydrophobic drug and the metabolites from endogenous binding moieties. The pretreated sample may be subjected to an assay for determining the hydrophobic drug.

Methods for detection of hydrophobic drugs

Methods and reagents are disclosed for enhancing the bioavailability of a hydrophobic drug, and in some embodiments for determining a hydrophobic drug, in a sample suspected of containing a hydrophobic drug. A combination is formed in a medium where the combination comprises the sample, a hemolytic agent where a determination of the hydrophobic drug is conducted, and a bioavailability agent for the hydrophobic drug. The bioavailability agent comprises an ionic detergent comprising a chain of at least 10 carbon atoms or a non-ionic detergent comprising a chain of at least 15 repeating ethylene oxide units or propylene oxide units or a combination of ethylene oxide units and propylene oxide units. The concentration of the bioavailability agent in the medium is sufficient to enhance the bioavailability of the hydrophobic drug. The medium is incubated under conditions for enhancing the bioavailability of the hydrophobic drug, and in a determination of the hydrophobic drug under conditions for hemolyzing cells in the sample. For determination of the hydrophobic drug, reagents for determining the presence and/or amount of the hydrophobic drug in the sample are added to the medium. The reagents comprise at least one antibody for the hydrophobic drug. The medium is examined for the presence of a complex comprising the hydrophobic drug and the antibody for the hydrophobic drug. The presence and/or amount of the complex indicates the presence and/or amount of the hydrophobic drug in the sample.

Methods for detection of immunosuppressant drugs

Methods and reagents are disclosed for pretreating a sample suspected of containing a hydrophobic drug for conducting an assay method for detecting the hydrophobic drug. A combination is provided in a medium. The combination comprises (i) the sample, (ii) a releasing agent for releasing the hydrophobic drug and the metabolites from endogenous binding moieties, and (iii) a selective solubility agent that provides for substantially equal solubility of the hydrophobic drug and the metabolites in the medium. The selective solubility agent comprises a water miscible, non-volatile organic solvent and is present in the medium in a concentration sufficient to provide for substantially equal solubility of the hydrophobic drug and the metabolites in the medium. The medium, which may further comprise a hemolytic agent, is incubated under conditions for releasing the hydrophobic drug and the metabolites from endogenous binding moieties. For conducting an assay for the hydrophobic drug, the above pretreatment is performed and to the medium is added reagents for determining the presence and/or amount of the hydrophobic drug in the sample wherein the reagents comprise at least one antibody for the hydrophobic drug. The medium is examined for the presence of a complex comprising the hydrophobic drug and the antibody for the hydrophobic drug, the presence and/or amount of the complex indicating the presence and/or amount of the hydrophobic drug in the sample.

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Cochranville, PA, United States of America

Amy Posey