Abstract: Lateral flow immunoassays that reliably detect human antibodies, including IgG and/or IgM antibodies, specific for severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) are described herein. Devices, methods and kits for analysis of samples, such as liquid blood, serum or plasma, for the presence of human antibodies, such as IgG and/or IgM antibodies, specific for SARS CoV-2 proteins, such as SARS CoV-2 N and/or S proteins are provided.

Abstract: A system comprised of an apparatus and a test device is described. The test device and the apparatus are designed to interact to determine the presence or absence of an analyte of interest in a sample placed on the test device.

Abstract: A system comprised of an apparatus and a test device is described. The test device and the apparatus are designed to interact to determine the presence or absence of an analyte of interest in a sample placed on the test device.

Abstract: A system comprised of an apparatus and a test device is described. The test device and the apparatus are designed to interact to determine the presence or absence of an analyte of interest in a sample placed on the test device. The test device and apparatus interact to provide a timer feature for determining a test device specific adjustable cut-off value that is used to ascertain whether signal from a test line in the device corresponds to a positive or negative results, irrespective of the time elapsed since placement of sample on the test device. The adjustable cut-off value renders the system relatively insensitive to incubation time of the test device, where if the incubation time is shorter or longer than needed for accuracy of a test result, the analyzer will report an invalid result, thus preventing the reporting of an incorrect (false negative or false positive) result.

Abstract: A system comprised of an apparatus and a test device is described. The test device and the apparatus are designed to interact to determine the presence or absence of an analyte of interest in a sample placed on the test device. The test device and apparatus interact to provide a timer feature for determining a test device specific adjustable cut-off value that is used to ascertain whether signal from a test line in the device corresponds to a positive or negative results, irrespective of the time elapsed since placement of sample on the test device. The adjustable cut-off value renders the system relatively insensitive to incubation time of the test device, where if the incubation time is shorter or longer than needed for accuracy of a test result, the analyzer will report an invalid result, thus preventing the reporting of an incorrect (false negative or false positive) result.

Abstract: Antibody fusions comprising any antibody or fragment thereof, operably linked, and expressed as a fusion with a label of interest are provided. Plasmids, vectors, host cells, methods, and kits related to the described antibody fusions are also provided. The antibody fusions are useful at least in the diagnostic and reagent setting.

Abstract: Kits, compositions, and methods useful in the diagnosis of thyroid diseases involving autoantibodies are provided.

Abstract: A system comprised of an apparatus and a test device is described. The test device and the apparatus are designed to interact to determine the presence or absence of an analyte of interest in a sample placed on the test device.

Abstract: Methods for preparing a sample for detection of an analyte of interest that is bound in vivo to a protein are provided. The method comprises providing a processing reagent comprising metaperiodate and contacting a sample suspected of comprising an analyte of interest associated with a protein with the processing reagent to form a mixture. The analyte of interest, if present in the sample (or mixture), is separated from its associated protein for detection of the analyte of interest. In one embodiment, the method is applied to samples for the detection of levels of vitamin D circulating in the blood. Samples are processed using the reagent disclosed herein to separate the analyte of interest, vitamin D or a metabolite thereof, from the vitamin D binding protein and/or albumin, for detection of the analyte separated from its binding protein(s).

Abstract: Methods for preparing a sample for detection of an analyte of interest that is bound in vivo to a protein are provided. The method comprises providing a processing reagent comprising metaperiodate and contacting a sample suspected of comprising an analyte of interest associated with a protein with the processing reagent to form a mixture. The analyte of interest, if present in the sample (or mixture), is separated from its associated protein for detection of the analyte of interest. In one embodiment, the method is applied to samples for the detection of levels of vitamin D circulating in the blood. Samples are processed using the reagent disclosed herein to separate the analyte of interest, vitamin D or a metabolite thereof, from the vitamin D binding protein and/or albumin, for detection of the analyte separated from its binding protein(s).

Abstract: A system comprised of an apparatus and a test device is described. The test device and the apparatus are designed to interact to determine the presence or absence of an analyte of interest in a sample placed on the test device.

Abstract: Methods for preparing a sample for detection of an analyte of interest that is bound in vivo to a protein are provided. The method comprises providing a processing reagent comprising metaperiodate and contacting a sample suspected of comprising an analyte of interest associated with a protein with the processing reagent to form a mixture. The analyte of interest, if present in the sample (or mixture), is separated from its associated protein for detection of the analyte of interest. In one embodiment, the method is applied to samples for the detection of levels of vitamin D circulating in the blood. Samples are processed using the reagent disclosed herein to separate the analyte of interest, vitamin D or a metabolite thereof, from the vitamin D binding protein and/or albumin, for detection of the analyte separated from its binding protein(s).

Abstract: A system comprised of an apparatus and a test device is described. The test device and the apparatus are designed to interact to determine the presence or absence of an analyte of interest in a sample placed on the test device.

Abstract: A system comprised of an apparatus and a test device is described. The test device and the apparatus are designed to interact to determine the presence or absence of an analyte of interest in a sample placed on the test device.

Abstract: A system comprised of a device for measuring hemoglobin content and/or determining a hematocrit value and/or measuring a hematocrit value, and a device for measuring or detecting an analyte, and a method for measuring or determining the presence of at least one analyte are described.

Abstract: A system comprised of an apparatus and a test device is described. The test device and the apparatus are designed to interact to determine the presence or absence of an analyte of interest in a sample placed on the test device.

Abstract: A system comprised of an apparatus and a test device is described. The test device and the apparatus are designed to interact to determine the presence or absence of an analyte of interest in a sample placed on the test device. The test device and apparatus interact to provide a timer feature for determining a test device specific adjustable cut-off value that is used to ascertain whether signal from a test line in the device corresponds to a positive or negative results, irrespective of the time elapsed since placement of sample on the test device. The adjustable cut-off value renders the system relatively insensitive to incubation time of the test device, where if the incubation time is shorter or longer than needed for accuracy of a test result, the analyzer will report an invalid result, thus preventing the reporting of an incorrect (false negative or false positive) result.

Abstract: This reagent strip is comprised of a testing portion which contains an absorbent cotton pad. This absorbent cotton pad may be placed in the mouth on the tongue to collect an oral fluid sample. A plastic frame surrounds the pad to help hold the fluid thereon. This testing strip contains at its opposite end a sealing mechanism for sealing engagement with a preservative pouch, and an oversized handle with a patient identifying mechanism. The preservative pouch of the present invention contains a pair of seals. The first seal, located proximally to the user, enables a preservative which is maintained within the pouch to be sealed during shipment of the pouch to the user. Thereafter, the user punctures the first seal upon placement of the reagent pad into the pouch. The sealing mechanism contained on the reagent pad then seals at the opening in the pouch to maintain the reagent pad in sealing arrangement within the pouch. At its distal end, the pouch contains a second sealing mechanism.

Abstract: This reagent strip is comprised of a testing portion which contains an absorbent cotton pad. This absorbent cotton pad may be placed in the mouth on the tongue to collect an oral fluid sample. A plastic frame surrounds the pad to help hold the fluid thereon. This testing strip contains at its opposite end a sealing mechanism for sealing engagement with a preservative pouch, and an oversized handle with a patient identifying mechanism. The preservative pouch of the present invention contains a pair of seals. The first seal, located proximally to the user, enables a preservative which is maintained within the pouch to be sealed during shipment of the pouch to the user. Thereafter, the user punctures the first seal upon placement of the reagent pad into the pouch. The sealing mechanism contained on the reagent pad then seals at the opening in the pouch to maintain the reagent pad in sealing arrangement within the pouch. At its distal end, the pouch contains a second sealing mechanism.