Abstract: 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.

Abstract: Methods and reagents are disclosed for detecting a false result in an assay measurement for determining a concentration of an analyte in a sample suspected of containing the analyte. The method comprises measuring assay signal resulting from background only and measuring assay signal resulting from the presence of analyte in the sample plus background and subtracting the first measurement from the second measurement to determine the concentration of analyte in the sample. For example, a measurement result 1 is determined by means of an assay conducted on a portion of the sample where analyte in the sample is substantially sequestered and a measurement result 2 is determined by means of the assay conducted on an equal portion of the same sample where analyte in the sample is substantially non-sequestered. Measurement result 1 is subtracted from measurement result 2 to determine the concentration of analyte in the sample.

Abstract: In some embodiments, the present invention pertains to a method for detecting an adulterant in a biological sample. A combination of a biological sample, an agent for detecting the adulterant and an ionic moiety capable of undergoing reduction by gaining electrons is provided in an assay medium. The combination is incubated under conditions sufficient for the ionic moiety to undergo reduction and for the agent for detecting the adulterant to interact with the adulterant. The reduction of the ionic moiety enhances the detection of the adulterant as a result of increasing the sensitivity of the agent for detecting the adulterant. The extent of interaction between the agent for detecting the adulterant and the adulterant is measured and is related to the presence or absence of the adulterant in the biological sample.

Abstract: The invention relates to methods and compositions for removing a dissociated species from a fluid medium solution during and after it has detached from a solid-phase immersed in said medium, thereby allowing the concentration of free species to remain close to zero, and for improving the signal to noise ratio in assays. This is achieved by employing a substrate, such as a scavenging solid-phase, having an attached binding partner or partners (“scavenger”) for the specifically binding species and which is present during storage. This substrate may also contain regions for binding signal generating components attached to the solid-phase. This substrate binds any free species bleeding off the solid phase, increasing the reliability and sensitivity of assays. A subset of the substrates in the invention additionally forms cross-linked networks of solid-phase particles that further increase the sensitivity of assays.

Abstract: 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.

Abstract: Methods and reagents are disclosed for conducting assays for IgE. Embodiments of the present reagents comprise a conjugate of a macromolecule and a compound comprising a galactose-?-1,3-galactose epitope. Embodiments of the present methods are directed to determining the presence and/or amount of an IgE specific for a galactose-?-1,3-galactose epitope in a sample. A combination is provided in a medium, which comprises the sample and a reagent for determining the presence and/or amount of an IgE specific for a galactose-?-1,3-galactose epitope in a sample wherein the reagent comprises a conjugate of a macromolecule and a compound comprising a galactose-?-1,3-galactose epitope. The combination is subjected to conditions for binding of the IgE to the reagent to form a complex. The presence and/or amount of the complex are detected and the amount of the complex is related to the presence and/or amount of IgE in the sample.

Abstract: A composition and kit useful as a tacrolimus standard solution for immunoassays, and methods for making and using same. The composition and kits include a known amount of tacrolimus or a derivative thereof, and a non-specific protein capable of forming a complex with the tacrolimus or derivative thereof. The standard solution may be used to generate calibration curves for an immunoassay or to check the precision of an analytical instrument.

Abstract: Methods and reagents are disclosed for conducting assays. Embodiments of the present methods and reagents are concerned with a solid support such as, for example, a particle. The support includes a chemiluminescent composition that includes a metal chelate. The present inventors observed that, when such support such as, e.g., particles, were employed in assays for the determination of an analyte, stability of signal output by the chemiluminescent composition associated with the particle was unacceptably reduced as compared to particles including other chemiluminescent compositions. In accordance with embodiments of the present invention, the stability of signal output from such particles is enhanced by including in a medium that contains the particles a sufficient amount of one or more stabilizing agents, which may be a chelating agent and/or a metal chelate such as, for example, the metal chelate that is associated with the particle.

Abstract: Methods and reagents are disclosed for detecting a false result in an assay for determining a concentration of an analyte in a whole blood sample suspected of containing the analyte. The method comprises determining by means of the assay a concentration of the analyte utilizing a hemolyzed portion of the blood sample to obtain concentration value 1 and determining by means of the assay a concentration of the analyte utilizing a non-hemolyzed portion of the blood sample and multiplying the concentration times a hematocrit factor to obtain concentration value 2. A ratio of concentration value 1 divided by concentration value 2 is determined and is compared to a predetermined ratio of known reliability. If the ratio is less than the predetermined ratio, a false result is indicated.

Abstract: 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.

Abstract: In some embodiments, the present invention pertains to a method for conjugating a first compound to a second compound wherein the conjugation involves an electrophilic moiety. The method comprises reacting the first compound with the second compound to form a conjugate. The improvement in embodiments of the present invention comprises adding a nucleophilic reagent to the conjugate wherein the nucleophilic reagent forms a neutral product upon reaction with unreacted electrophilic moieties of the conjugate. In some embodiments, the nucleophilic reagent is substantially non-reactive with disulfide bonds in the event that the conjugate comprises disulfide bonds. The conjugate formed is doubly deactivated because the other moiety for linking to the electrophilic moiety is also deactivated.

Abstract: An IgG1? monoclonal antibody to the immunosuppressive drug tacrolimus has improved properties. In particular, this monoclonal antibody, designated 1H6, has reduced cross-reactivity to several tacrolimus metabolites. This antibody is suitable for performance of immunoassays such as homogeneous immunoassays to detect or determine the presence or concentration of tacrolimus in samples such as blood samples. The invention further includes derivatives of tacrolimus derivatized at a non-binding portion of the molecule useful in immunizing antibody-producing animals and in producing such monoclonal antibodies, as well as labeled derivatives of tacrolimus useful as tacrolimus analogues in such assays. The invention further includes immunoassay methods for the detection of tacrolimus and test kits useful in performing such immunoassays.

Abstract: Methods and kits for determining sirolimus in a sample known or suspected to contain sirolimus are provided. The methods and kits according to the invention use one or more antibodies generated using a fragment of sirolimus, such as the northern fragment of sirolimus.

Abstract: Methods, compositions and kits are disclosed for identifying patients with an increased risk of experiencing an adverse cardiovascular event where the patient is undergoing aspirin antiplatelet therapy. A platelet-containing sample from the patient is evaluated for platelet hyperactivity and platelet hyperactivity in the sample is related to the patient's risk of an adverse cardiovascular event. In some embodiments the evaluation for platelet hyperactivity is carried out by assessing the function of platelets in the sample using a high shear platelet function test.

Abstract: 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.

Abstract: Methods, compositions and kits are disclosed directed at haptens, immunogens and immnoassays for buprenorphine (BUP) and nor buprenorphine (norBUP). The method comprises providing in combination in a medium (i) a sample suspected of containing buprenorphine (BUP) or norbuprenorphine (norBUP) and (ii) an antibody raised against an immunogen of buprenorphine (BUP) or norbuprenorphine (norBUP). The medium is examined for the presence of a complex comprising a labeled hapten of buprenorphine (BUP) or norbuprenorphine (norBUP) where the presence of such as complex indicates the presence of the compound in the sample.

Abstract: The present invention relates to immobilized procainamide analogs, as well as to a method of making immobilized procainamide analogs. These immobilized analogs are prepared by activating the carboxyl group on a substituted p-benzoic acid derivative toward nucleophilic attack; reacting the activated benzoic acid derivative with a polyamine to produce the benzoic acid derivative of Formula 3: and binding the benzoic acid derivative of Formula 3 to a latex polymer having functional groups that react with aliphatic amino groups. A method of conducting an immunoassay using the immobilized procainamide analog Formula 3 is described, comprising the steps of preparing a solution comprising said immobilized procainamide analog; adding a sample suspected of containing procainamide to said solution; adding an anti-procainamide antibody to said solution and observing the rate of increase in solution turbidity following antibody addition.

Abstract: Reagents are disclosed for use in assays for analytes. The reagents are dry assay reagents that may be readily reconstituted for use in the assays. The dry assay reagents comprise a solid support and one or more molecules of a receptor immobilized on the solid support. The receptor comprises one or more binding sites for a ligand. A portion of a total number of the binding sites is bound to a conjugate comprising the ligand linked to a specific binding pair member and a portion of the total number of the binding sites is free. In use in an assay, a combination is provided in an aqueous medium comprising the sample and reagents for detecting the analyte wherein at least one of the reagents comprises the dry assay reagent mentioned above. The combination is incubated under conditions for binding of the analyte to one or more of the reagents.

Abstract: 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.

Abstract: Methods, compositions and kits are disclosed. The compositions are light emitting and comprise a polymeric matrix having dissolved therein a photoactive compound. The composition has the characteristic that, after activation of the photoactive compound, the rate of decrease in the intensity of light emission at any time during a 20-fold decrease in the intensity is proportional to the intensity of the light emission. In one embodiment the polymeric matrix is comprised of particles of about 20 nm to about 100 ?m in diameter to which is bound a specific binding pair member. The particles generally comprise a polymeric matrix having dissolved therein about 1 to about 20% by weight of a dopant. The compositions may be used in methods for determining an analyte. A combination is provided comprising (1) a medium suspected of containing the analyte, (2) and the aforementioned composition. The photoactive substance is activated and the effect of the activating on the optical properties of the combination is detected.