Abstract: The present invention discloses compositions that comprise compounds relating to vitamin D. These compounds are useful for assays in the determination and distinguishing of certain 3-epimeric 25 hydroxyvitamin D and non-epimeric 25 hydroxyvitamin D. The compositions of the present invention may be used for example as immunogens used to develop antibodies to certain vitamin D compounds or conjugates used in assays for certain vitamin D compounds or used as a solid phase reagent in assays. The composition comprises a compound of one or more of the generic formula (R1)p-(L)q-Z.

Abstract: Compounds include compounds of the Formula I, namely, (R1)p-(L)q-Z wherein R1, L, p and q are as defined herein.

Abstract: This invention relates to compositions, methods and kits for determining the presence and/or amount of vitamin D analytes, including vitamin D isomers, and metabolites thereof in a sample suspected of containing the same. Compounds include compounds of the Formula I, namely, (R1)p-(L)q-Z wherein R1, L, p and q are as defined herein. These compounds are capable of binding specifically to corresponding antibodies. Compounds and antibodies in accordance with the principles described herein can have therapeutic activity. These compounds may be administered in therapeutically effective amount, which is an amount to provide treatment of a particular disease state associated with vitamin D. Administration of the examples of compounds in accordance with the principles described herein can be by means of any of the accepted modes of administration for agents that serve similar utilities.

Abstract: Antibodies are raised against compounds of Formula (I) where Z is an immunogenic carrier. These compounds are capable of binding specifically to corresponding antibodies. The antibodies are specific for epimers of vitamin D. Antibodies in accordance with the principles described herein may be employed to minimize or eliminate 3-epimer cross-reactivity in assays for non-epimeric forms of vitamin D analytes. Over-estimation of total non-epimeric vitamin D analyte caused by the cross-reactivity of 3-epimer vitamin D with an antibody for vitamin D analyte can be substantially avoided employing, as blocking agents, antibodies prepared against immunogens that are a compound of the Formula (I) wherein Z is an immunogenic carrier.

Abstract: Methods include determining an amount of an epimeric vitamin D analyte in a sample suspected of containing the epimeric vitamin D analyte. A combination is provided in an assay medium that includes the sample and a vitamin D epimer antibody that is specific for the epimeric vitamin D analyte. The assay medium is incubated under conditions for binding of the vitamin D epimer antibody to the epimeric vitamin D analyte to form an epimeric vitamin D antibody-bound complex. The amount of the epimeric vitamin D antibody-bound complex is determined and related to the amount of epimeric vitamin D analyte in the sample.

Abstract: Methods include determining an amount of vitamin D analyte in a sample suspected of containing the vitamin D analyte. A combination is provided in an assay medium that includes the sample, a vitamin D epimer antibody that is specific for epimers of the vitamin D analyte wherein the vitamin D epimer antibody does not bind to any detectable degree to the vitamin D analyte, and a vitamin D antibody that is specific for the vitamin D analyte, and. The assay medium is incubated under conditions for binding of the vitamin D epimer antibody to the epimers of the vitamin D analyte and for binding of the vitamin D antibody to the vitamin D analyte to form a vitamin D antibody-bound complex. The amount of vitamin D antibody-bound complex is determined and related to the amount of vitamin D analyte in the sample.

Abstract: Methods include determining an amount of vitamin D analyte in a sample suspected of containing the vitamin D analyte. A combination is provided in an assay medium that includes the sample, a vitamin D epimer antibody that is specific for epimers of the vitamin D analyte wherein the vitamin D epimer antibody does not bind to any detectable degree to the vitamin D analyte, and a vitamin D antibody that is specific for the vitamin D analyte, and. The assay medium is incubated under conditions for binding of the vitamin D epimer antibody to the epimers of the vitamin D analyte and for binding of the vitamin D antibody to the vitamin D analyte to form a vitamin D antibody-bound complex. The amount of vitamin D antibody-bound complex is determined and related to the amount of vitamin D analyte in the sample.

Abstract: Methods include determining an amount of an epimeric vitamin D analyte in a sample suspected of containing the epimeric vitamin D analyte. A combination is provided in an assay medium that includes the sample and a vitamin D epimer antibody that is specific for the epimeric vitamin D analyte. The assay medium is incubated under conditions for binding of the vitamin D epimer antibody to the epimeric vitamin D analyte to form an epimeric vitamin D antibody-bound complex. The amount of the epimeric vitamin D antibody-bound complex is determined and related to the amount of epimeric vitamin D analyte in the sample.

Abstract: Methods and reagents are disclosed for determining a total amount of an analyte in an unknown sample suspected of containing the analyte in the presence of endogeneous interfering substances. The methods involve measuring an amount [Y] of the portion of the analyte in the unknown sample that is bound by endogeneous binding substances employing an assay for the analyte. An amount [Z] of analyte in the unknown sample that is not bound by endogeneous binding substances is determined by the formula: [Z]=a[Y]+b, wherein “a” and “b” are predetermined by conducting the assay on samples containing known amounts of the analyte but substantially free from endogeneous interfering substances. Adding [Y] and [Z] yields the total amount [X] of the analyte in the unknown sample.

Abstract: Antibodies are raised against compounds of Formula (I) where Z is an immunogenic carrier. These compounds are capable of binding specifically to corresponding antibodies. The antibodies are specific for epimers of vitamin D. Antibodies in accordance with the principles described herein may be employed to minimize or eliminate 3-epimer cross-reactivity in assays for non-epimeric forms of vitamin D analytes. Over-estimation of total non-epimeric vitamin D analyte caused by the cross-reactivity of 3-epimer vitamin D with an antibody for vitamin D analyte can be substantially avoided employing, as blocking agents, antibodies prepared against immunogens that are a compound of the Formula (I) wherein Z is an immunogenic carrier.

Abstract: This invention relates to compositions, methods and kits for determining the presence and/or amount of vitamin D analytes, including vitamin D isomers, and metabolites thereof in a sample suspected of containing the same. Compounds include compounds of the Formula I, namely, (R1)p-(L)q-Z wherein R1, L, p and q are as defined herein. These compounds are capable of binding specifically to corresponding antibodies. Compounds and antibodies in accordance with the principles described herein can have therapeutic activity. These compounds may be administered in therapeutically effective amount, which is an amount to provide treatment of a particular disease state associated with vitamin D. Administration of the examples of compounds in accordance with the principles described herein can be by means of any of the accepted modes of administration for agents that serve similar utilities.

Abstract: Methods are disclosed for determining an immunosuppressant drug in a sample suspected of containing an immunosuppressant drug. The method includes providing in combination in a medium the sample, a first monoclonal antibody for the immunosuppressant drug, and a second monoclonal antibody for the immunosuppressant drug. The second monoclonal antibody binds to a portion of the immunosuppressant drug other than the portion to which the first monoclonal antibody binds to the immunosuppressant drug. The medium is incubated under conditions for binding of the first monoclonal antibody and the second monoclonal antibody to the immunosuppressant drug. The medium is examined for the presence of an immunocomplex comprising the immunosuppressant drug, the first monoclonal antibody and the second monoclonal antibody. The presence and/or amount of the immunocomplex indicates the presence and/or amount of the immunosuppressant drug in the sample.

Abstract: Methods and reagents are disclosed for determining a total amount of an analyte in an unknown sample suspected of containing the analyte in the presence of endogeneous interfering substances. The methods involve measuring an amount [Y] of the portion of the analyte in the unknown sample that is bound by endogeneous binding substances employing an assay for the analyte. An amount [Z] of analyte in the unknown sample that is not bound by endogeneous binding substances is determined by the formula: [Z]=a[Y]+b, wherein “a” and “b” are predetermined by conducting the assay on samples containing known amounts of the analyte but substantially free from endogeneous interfering substances. Adding [Y] and [Z] yields the total amount [X] of the analyte in the unknown sample.

Abstract: Methods are disclosed for determining an immunosuppressant drug in a sample suspected of containing an immunosuppressant drug. The method includes providing in combination in a medium the sample, a first monoclonal antibody for the immunosuppressant drug, and a second monoclonal antibody for the immunosuppressant drug. The second monoclonal antibody binds to a portion of the immunosuppressant drug other than the portion to which the first monoclonal antibody binds to the immunosuppressant drug. The medium is incubated under conditions for binding of the first monoclonal antibody and the second monoclonal antibody to the immunosuppressant drug. The medium is examined for the presence of an immunocomplex comprising the immunosuppressant drug, the first monoclonal antibody and the second monoclonal antibody. The presence and/or amount of the immunocomplex indicates the presence and/or amount of the immunosuppressant drug in the sample.

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 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 compositions are disclosed for reducing non-specific binding in a binding assay for the determination of an analyte in a sample where one of the reagents for conducting the binding assay comprises a solid support comprising a polysaccharide. The method comprises including in an assay medium for conducting the binding assay a soluble compound comprising a protein linked to a polysaccharide. Also disclosed are methods and compositions for determining the presence and/or amount of an analyte in a sample suspected of containing the analyte. The methods include as reagents a solid support comprising a polysaccharide and a soluble compound comprising a protein linked to a polysaccharide.

Abstract: Methods and compositions are disclosed for reducing non-specific binding in a binding assay for the determination of an analyte in a sample where one of the reagents for conducting the binding assay comprises a solid support comprising a polysaccharide. The method comprises including in an assay medium for conducting the binding assay a soluble compound comprising a protein linked to a polysaccharide. Also disclosed are methods and compositions for determining the presence and/or amount of an analyte in a sample suspected of containing the analyte. The methods include as reagents a solid support comprising a polysaccharide and a soluble compound comprising a protein linked to a polysaccharide.

Abstract: Automatically rejecting outlier measurements in an analytical method employing multiple photometric values by determining the photometric value that is involved in the pair of photometric values having the greatest variance between individual mean rates and the mean rate of all of the multiple photometric values.

Abstract: Calibrating an immunoassay by generating two reaction rate measuring curves, from samples having higher and lower relative levels of antigen, extrapolating a combination of the curves to cover sample concentrations known to contain an excess of antigen relative to an amount of capture reagent and combining the low end linear potion of the higher reaction rate measuring curve with the higher end portion of the extrapolated reaction rate measuring curve, thereby eliminating measuring inaccuracies otherwise arising from the hook effect. For antigen concentrations higher than the assay range, a high antigen signal utilizing the two rates avoids reporting false results.