Abstract: A method for analyzing the results of a ligand-receptor binding assay comprising the steps of: (a) providing the results of a ligand-receptor binding assay; and (b) qualifying the results of a ligand-receptor binding assay. More particularly, the ligand-receptor binding assay involves the steps of combining appropriate reagents in which receptors attached to a solid support, a sample suspected of containing a ligand, and a conjugate comprising a label form a complex in which the label is present at a concentration that is directly proportional to the amount of ligand present in the sample. Alternatively, the ligand-receptor binding assay involves the steps of combining appropriate reagents to perform a ligand-receptor binding assay in which receptors attached to a solid support, a sample suspected of containing a ligand, and a conjugate comprising a label form a complex in which the label is present at a concentration that is inversely proportional to the amount of analyte present in the sample.

Abstract: A method for analyzing the results of a ligand-receptor binding assay comprising the steps of: (a) providing the results of a ligand-receptor binding assay; and (b) qualifying the results of a ligand-receptor binding assay. More particularly, the ligand-receptor binding assay involves the steps of combining appropriate reagents in which receptors attached to a solid support, a sample suspected of containing a ligand, and a conjugate comprising a label form a complex in which the label is present at a concentration that is directly proportional to the amount of ligand present in the sample. Alternatively, the ligand-receptor binding assay involves the steps of combining appropriate reagents to perform a ligand-receptor binding assay in which receptors attached to a solid support, a sample suspected of containing a ligand, and a conjugate comprising a label form a complex in which the label is present at a concentration that is inversely proportional to the amount of analyte present in the sample.

Abstract: A method for analyzing the results of a ligand-receptor binding assay comprising the steps of: (a) providing the results of a ligand-receptor binding assay; and (b) qualifying the results of a ligand-receptor binding assay. More particularly, the ligand-receptor binding assay involves the steps of combining appropriate reagents in which receptors attached to a solid support, a sample suspected of containing a ligand, and a conjugate comprising a label form a complex in which the label is present at a concentration that is directly proportional to the amount of ligand present in the sample. Alternatively, the ligand-receptor binding assay involves the steps of combining appropriate reagents to perform a ligand-receptor binding assay in which receptors attached to a solid support, a sample suspected of containing a ligand, and a conjugate comprising a label form a complex in which the label is present at a concentration that is inversely proportional to the amount of analyte present in the sample.

Abstract: The instant disclosure provides methods of multi-assay processing and multi-assay analysis. Such multi-assay processing and analysis pertain to automated detection of target nucleic acids, e.g., as performed in the clinical setting for diagnostic purposes. Also provided are common assay timing protocols derived from a variety of individual nucleic acid amplification and analysis protocols and modified to prevent resource contention. The instant disclosure also provides systems and devices for practicing the methods as described herein.

Abstract: Aspects of the present disclosure include sample preparation cartridges including a frame that includes a plurality of wells integrated therewith, where the plurality of wells have a closed bottom and an open top. The frame further includes an opening within the frame having a reaction vessel (RV) or RV cap removably disposed therein, where the plurality of wells and the opening are linearly arranged relative to each other. Also provided are sample preparation cartridges that include a frame, two or more cartridge separation projections on a top side of the frame, and two or more cartridge separation projections on a bottom side of the frame. The cartridge separation projections separate the cartridge and a different cartridge when the cartridge and different cartridge are stacked. Methods of using the sample preparation cartridges, as well as nucleic acid sample preparation units that include the sample preparation cartridges, are also provided.

Abstract: The instant disclosure provides methods of multi-assay processing and multi-assay analysis. Such multi-assay processing and analysis pertain to automated detection of target nucleic acids, e.g., as performed in the clinical setting for diagnostic purposes. Also provided are common assay timing protocols derived from a variety of individual nucleic acid amplification and analysis protocols and modified to prevent resource contention. The instant disclosure also provides systems and devices for practicing the methods as described herein.

Abstract: Aspects of the present disclosure include sample analysis methods and systems. According to certain embodiments, provided are methods of analyzing samples in an automated sample analysis system. The methods include introducing samples and sample preparation cartridges into the system, isolating and purifying an analyte (e.g., nucleic acids and/or proteins) present in the samples at a sample preparation station, and performing analyte detection assays in assay mixtures that include the purified analyte. Also provided are automated sample analysis systems that find use, e.g., in performing the methods of the present disclosure. In certain aspects, the methods and systems provide for continuous operator access during replenishment or removal of one or any combination of samples, bulk fluids, reagents, commodities, waste, and/or the like.

Abstract: Provided herein are assays and kits useful for avoiding “prozone phenomenon” or “hook effect” and which expand the range of accurately measurable analyte concentrations.

Abstract: Aspects of the present disclosure include sample analysis methods and systems. According to certain embodiments, provided are methods of analyzing samples in an automated sample analysis system. The methods include introducing samples and sample preparation cartridges into the system, isolating and purifying an analyte (e.g., nucleic acids and/or proteins) present in the samples at a sample preparation station, and performing analyte detection assays in assay mixtures that include the purified analyte. Also provided are automated sample analysis systems that find use, e.g., in performing the methods of the present disclosure. In certain aspects, the methods and systems provide for continuous operator access during replenishment or removal of one or any combination of samples, bulk fluids, reagents, commodities, waste, and/or the like.

Abstract: The disclosure provides a method for an enhanced detection of an analyte present in a biological sample. After the formation of the analyte/specific binding member(s)/detectable label complex, the labels are eluted and a first aliquot of eluant is brought into contact with a solid support, wherein the solid support comprises immobilized thereto specific binding member that specifically binds to the label, removing the first aliquot from the solid support and contacting the solid support with a second aliquot of the eluted label, and repeating the above steps, such that the label is concentrated on the solid support for further analysis to quantify the analyte in the biological sample.

Abstract: A method for analyzing the results of a ligand-receptor binding assay comprising the steps of: (a) providing the results of a ligand-receptor binding assay; and (b) qualifying the results of a ligand-receptor binding assay. More particularly, the ligand-receptor binding assay involves the steps of combining appropriate reagents in which receptors attached to a solid support, a sample suspected of containing a ligand, and a conjugate comprising a label form a complex in which the label is present at a concentration that is directly proportional to the amount of ligand present in the sample. Alternatively, the ligand-receptor binding assay involves the steps of combining appropriate reagents to perform a ligand-receptor binding assay in which receptors attached to a solid support, a sample suspected of containing a ligand, and a conjugate comprising a label form a complex in which the label is present at a concentration that is inversely proportional to the amount of analyte present in the sample.

Abstract: A method for analyzing the results of a ligand-receptor binding assay comprising the steps of: (a) providing the results of a ligand-receptor binding assay; and (b) qualifying the results of a ligand-receptor binding assay. More particularly, the ligand-receptor binding assay involves the steps of combining appropriate reagents in which receptors attached to a solid support, a sample suspected of containing a ligand, and a conjugate comprising a label form a complex in which the label is present at a concentration that is directly proportional to the amount of ligand present in the sample. Alternatively, the ligand-receptor binding assay involves the steps of combining appropriate reagents to perform a ligand-receptor binding assay in which receptors attached to a solid support, a sample suspected of containing a ligand, and a conjugate comprising a label form a complex in which the label is present at a concentration that is inversely proportional to the amount of analyte present in the sample.

Abstract: Provided herein are assays and kits useful for avoiding “prozone phenomenon” or “hook effect” and which expand the range of accurately measurable analyte concentrations.

Abstract: Provided herein are assays and kits useful for avoiding “prozone phenomenon” or “hook effect” and which expand the range of accurately measurable analyte concentrations.

Abstract: The instant disclosure provides methods of multi-assay processing and multi-assay analysis. Such multi-assay processing and analysis pertain to automated detection of target nucleic acids, e.g., as performed in the clinical setting for diagnostic purposes. Also provided are common assay timing protocols derived from a variety of individual nucleic acid amplification and analysis protocols and modified to prevent resource contention. The instant disclosure also provides systems and devices for practicing the methods as described herein.

Abstract: Aspects of the present disclosure include sample preparation cartridges including a frame that includes a plurality of wells integrated therewith, where the plurality of wells have a closed bottom and an open top. The frame further includes an opening within the frame having a reaction vessel (RV) or RV cap removably disposed therein, where the plurality of wells and the opening are linearly arranged relative to each other. Also provided are sample preparation cartridges that include a frame, two or more cartridge separation projections on a top side of the frame, and two or more cartridge separation projections on a bottom side of the frame. The cartridge separation projections separate the cartridge and a different cartridge when the cartridge and different cartridge are stacked. Methods of using the sample preparation cartridges, as well as nucleic acid sample preparation units that include the sample preparation cartridges, are also provided.

Abstract: Aspects of the present disclosure include sample analysis methods and systems. According to certain embodiments, provided are methods of analyzing samples in an automated sample analysis system. The methods include introducing samples and sample preparation cartridges into the system, isolating and purifying an analyte (e.g., nucleic acids and/or proteins) present in the samples at a sample preparation station, and performing analyte detection assays in assay mixtures that include the purified analyte. Also provided are automated sample analysis systems that find use, e.g., in performing the methods of the present disclosure. In certain aspects, the methods and systems provide for continuous operator access during replenishment or removal of one or any combination of samples, bulk fluids, reagents, commodities, waste, and/or the like.

Abstract: The invention relates to antibody characteristics used to design a whole blood Point of Care Thyroid Stimulating Hormone (TSH) immunoassay using an ELISA sandwich assay lacking one or more wash steps between the antigen capture, detection antibody addition and substrate introduction steps. This invention exhibits low cross reactivity with biologically similar interfering cross reacting species, such as Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and Chorionic Gonadotropin (CG).

Abstract: The invention relates to low wash Thyroid Stimulating Hormone (TSH) immunoassays using an ELISA sandwich assay having limited or no wash step between the antigen capture, detection antibody addition and substrate introduction steps. This invention exhibits low cross reactivity with biologically similar interfering cross reacting species, such as Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and Chorionic Gonadotropin (CG).

Abstract: The invention relates to low wash Thyroid Stimulating Hormone (TSH) immunoassays using an ELISA sandwich assay having limited or no wash step between the antigen capture, detection antibody addition and substrate introduction steps. This invention exhibits low cross reactivity with biologically similar interfering cross reacting species, such as Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and Chorionic Gonadotropin (CG).