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 conducting assays. Embodiments of the present methods and reagents are concerned with chemiluminescent reagents for determining the presence and/or amount of an analyte in a sample suspected of containing the analyte. The reagent is non-particulate and comprises a binding partner for the analyte and a chemiluminescent composition comprising an olefinic compound and a metal chelate. In embodiments of an assay, a combination is provided that comprises a sample suspected of containing the analyte, a chemiluminescent reagent as described above and a sensitizer reagent capable of generating singlet oxygen. The combination is subjected to conditions for binding of the analyte to the binding partner for the analyte. The sensitizer is activated and the amount of luminescence generated by the chemiluminescent composition is detected wherein the amount of luminescence is related to the amount of the analyte in the sample.

Abstract: Methods are disclosed for designing an antibody reagent for use in an assay for the detection of an analyte to obtain an optimum assay sensitivity and/or dynamic range. The antibody reagent is a conjugate of a small molecule attached by a spacer group to an antibody for the analyte. The method comprises controlling, in the preparation of the conjugate, reaction parameters comprising the hydrophobicity or hydrophilicity of the spacer group, the length of the spacer group, the number of molecules of the small molecule attached to the antibody and the point of attachment of the small molecule to the antibody to obtain an optimum assay sensitivity and/or dynamic range.

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 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.