G01N33/96

COMPOSITIONS AND METHODS FOR CALIBRATION AND QUALITY CONTROL

The disclosure features calibration fluids that include a plurality of beads, such as cellulose, silica, poly(methyl-methacrylate) (PMMA), melamine, cross-linked agarose, polyvinylacetate (PVA), and/or polystyrene beads, where the beads are sized and colored to represent at least one type of blood cell; and a carrier fluid, that can include a polymer or polymerizing matrix, e.g., a water-soluble resin, e.g., an acrylic or polyurethane water-soluble resin or a starch or a cellulose, serum, and/or one or more or sugars. The disclosure also features methods of using the calibration fluids to calibrate automated sample preparation systems, such as automated hematology analyzer systems, e.g., image-based hematology analyzer systems.

COMPOSITIONS AND METHODS FOR CALIBRATION AND QUALITY CONTROL

The disclosure features calibration fluids that include a plurality of beads, such as cellulose, silica, poly(methyl-methacrylate) (PMMA), melamine, cross-linked agarose, polyvinylacetate (PVA), and/or polystyrene beads, where the beads are sized and colored to represent at least one type of blood cell; and a carrier fluid, that can include a polymer or polymerizing matrix, e.g., a water-soluble resin, e.g., an acrylic or polyurethane water-soluble resin or a starch or a cellulose, serum, and/or one or more or sugars. The disclosure also features methods of using the calibration fluids to calibrate automated sample preparation systems, such as automated hematology analyzer systems, e.g., image-based hematology analyzer systems.

Blood unit tests kit
11579153 · 2023-02-14 · ·

A diagnostic biological array, kit or system, and method of using same unit for conducting simultaneously blood tests and determining the presence of diseases, the blood type, and blood quality of a blood sample and its applications.

RECOMBINANT C-REACTIVE PROTEIN
20230039528 · 2023-02-09 · ·

The accuracy of immunoassay using a latex reagent is improved in a high CRP concentration range. Provided are C-reactive proteins generated by genetic recombination, 55% or more of the C-reactive proteins having a pyroglutamylated N-terminal.

Methods and Compositions in Diagnosis of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis

The present disclosure provides methods and compositions that find use in facilitating a diagnosis of chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) in a subject. The methods and compositions involve measurement of at least one of proteins: IL-16, IL-7, VEGF, CXCL9, CX3CL1, CCL24, CCL19, and CCL11 in a body fluid sample of a subject suspected of having CFS/ME. Levels of one or more of the aforementioned proteins can be used to facilitate a diagnosis of a CFS/ME and/or confirm a diagnosis of CFS/ME. The methods and compositions of the present disclosure also find use in screening subjects for clinical trials and facilitating treatment decisions for a subject.

Methods and Compositions in Diagnosis of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis

The present disclosure provides methods and compositions that find use in facilitating a diagnosis of chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) in a subject. The methods and compositions involve measurement of at least one of proteins: IL-16, IL-7, VEGF, CXCL9, CX3CL1, CCL24, CCL19, and CCL11 in a body fluid sample of a subject suspected of having CFS/ME. Levels of one or more of the aforementioned proteins can be used to facilitate a diagnosis of a CFS/ME and/or confirm a diagnosis of CFS/ME. The methods and compositions of the present disclosure also find use in screening subjects for clinical trials and facilitating treatment decisions for a subject.

STANDARD SUBSTANCE FOR PSA QUANTIFICATION, PREPARATION METHOD THEREFOR, STANDARD SOLUTION FOR PSA QUANTIFICATION, AND PSA QUANTIFICATION METHOD

An object of the present invention is to provide a standard substance for quantification of PSA having a specific sugar chain that can be used in a general purpose quantification, wherein the standard substance has less unbalanced sugar chain expression patterns, can be manufactured with high reproducibility, and enables the quantification of patient's sample comprising a high concentration of PSA, and preparation method therefor, standard solution for PSA quantification, and PSA quantification method. The standard substance comprises a compound having the structure of a PSA with a sugar chain represented by any of the following formulae A to D, and is isolated and purified from a natural product, chemically or enzymatically altered from a natural product, or the compound is artificially synthesized.

Detection Kit for Detecting Immunosuppressors in Whole Blood by High Performance Liquid Chromatography-Tandem Mass Spectrometry and Detection Method Thereof
20220404380 · 2022-12-22 ·

A detection kit for detecting an immunosuppressor in whole blood by high performance liquid chromatography-tandem mass spectrometry and a detection method thereof is provided. An internal standard solution is added with an antioxidant, vitamin E, and mixed with an internal standard diluent containing zinc sulfate heptahydrate, purified water and methanol for sample pretreatment, which not only exerts the function of the internal standard, but also synchronously achieves erythrocyte treatment, protein precipitation and target substance extraction. Various embodiments enable the immunosuppressor to be more stable in a solution matrix, thus promoting the detection accuracy and sensitivity. Various embodiments adopt isotopically-labeled sirolimus as an internal standard of everolimus to substitute isotopically-labeled everolimus, thus overcoming the interference of everolimus on isotopically-labeled everolimus and satisfying the detection requirements. Various embodiments detect four immunosuppressors simultaneously to reduce the cost of the internal standard, and has a lower detection cost, more accurate and stable detection results.

Detection Kit for Detecting Immunosuppressors in Whole Blood by High Performance Liquid Chromatography-Tandem Mass Spectrometry and Detection Method Thereof
20220404380 · 2022-12-22 ·

A detection kit for detecting an immunosuppressor in whole blood by high performance liquid chromatography-tandem mass spectrometry and a detection method thereof is provided. An internal standard solution is added with an antioxidant, vitamin E, and mixed with an internal standard diluent containing zinc sulfate heptahydrate, purified water and methanol for sample pretreatment, which not only exerts the function of the internal standard, but also synchronously achieves erythrocyte treatment, protein precipitation and target substance extraction. Various embodiments enable the immunosuppressor to be more stable in a solution matrix, thus promoting the detection accuracy and sensitivity. Various embodiments adopt isotopically-labeled sirolimus as an internal standard of everolimus to substitute isotopically-labeled everolimus, thus overcoming the interference of everolimus on isotopically-labeled everolimus and satisfying the detection requirements. Various embodiments detect four immunosuppressors simultaneously to reduce the cost of the internal standard, and has a lower detection cost, more accurate and stable detection results.

ANTIGEN ANALOGUE FOR IMMUNOMETRIC DIAGNOSTIC ASSAYS AND METHOD OF USE THEREOF

An antigen with an increased half-life is provided for the formulation of more stable and consistent clinical diagnostic immunoassay controls and calibrators. An antigen analogue comprises a first and a second polypeptide which is identical or similar to corresponding terminal amino acid sequences of an antigen. The first and second polypeptides are connected with a PEG chain. Also provided are methods of calibrating assays using a compound disclosed herein.