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The ALPI method is an in vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma on the Dimension Vista® System. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. ALPI CAL is an in vitro diagnostic product for the calibration of alkaline phosphatase (ALPI) method on the Dimension Vista® System.

The ALPI method employs alkaline phosphatase that catalyzes the transphosphorylation of pnitrophenylphosphate (p-NPP) to p-nitrophenol (p-NP) in the presence of the transphosphorylating buffer, 2 amino-2-methyl-1-propanol (AMP). The reaction is enhanced through the use of magnesium and zinc ions. The change in absorbance at 405 nm due to the formation of p-NP is directly proportional to the ALP activity, since other reactants are present in non-rate limiting quantities and is measured using a bichromatic (405, 510 nm) rate technique. p-NPP + AMP -> p-NP + AMP + PO4 (reaction conditions: pH 10.25, Mg/Zn) The ALPI CAL is a one (1) level, liquid calibrator. It is packaged as a kit of three vials of Calibrator A (Level 2) with 1.0 mL per vial. The product matrix is a human serum albumin based product containing alkaline phosphatase from porcine kidney. Level 1 is a zero level (system water). Level 2 contains alkaline phosphatase at 1000 U/L. This product is sold separately from the Flex® reagent cartridge. Values are assigned to new lots from a Masterpool that is from an International Federation of Clinical Chemistry (IFCC) reference.

The ALPI method is an in vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma on the Dimension® clinical chemistry system. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. ALPI CAL is an in vitro diagnostic product for the calibration of alkaline phosphatase (ALPI) method on the Dimension® clinical chemistry system.

The ALPI method employs alkaline phosphatase that catalyzes the transphosphorylation of pnitropheny | phosphate (p-NPP) to p-nitrophenol (p-NP) in the presence of the transphosphorylating buffer, 2 amino-2-methyl-1-propanol (AMP). The reaction is enhanced through the use of magnesium and zinc ions. The change in absorbance at 405 nm due to the formation of p-NP is directly proportional to the ALP activity, since other reactants are present in non-rate limiting quantities and is measured using a bichromatic (405, 510 nm) rate technique. The ALPI CAL is a three (3) level, liquid calibrator. It is packaged as a kit of six vials, two vials per level (1, 2 and 3) with 1.0 mL per vial. The product matrix is a human serum albumin based product containing alkaline phosphatase from porcine kidney. Levels 2 and 3 contain alkaline phosphatase at the following concentrations. Level 1: 0 U/L Level 2: 500 U/L Level 3: 1000 U/L This product is sold separately from the Flex® reagent cartridge. Values are assigned to new lots from a Masterpool that is from an International Federation of Clinical Chemistry (IFCC) reference.

The Bayer ADVIA IMS alkaline phosphatase (ALP) assay is an in-vitro diagnostic device intended to measure ALP in human serum or plasma. Such measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This diagnostic method is not intended for use on any other diagnostic system. This in vitro method is intended to quantitatively measure calcium in human serum and plasma on the Bayer ADVIA IMS. Measurements of calcium are used in the diagnosis, monitoring and treatment of a variety of diseases including parathyroid disease, a variety of bone diseases, chronic renal disease and tetany. The Bayer ADVIA IMS Glucose assay is an in vitro diagnostic device intended to measure glucose in human serum or plasma. Such measurements are used in the diagnosis, monitoring and treatment of carbohydrate metabolism disorders, including diabetes mellitus and neonatal hypoglycemia. This diagnostic method is not intended for use on any other diagnostic system. The Bayer ADVIA IMS Ferritin assay is an in vitro diagnostic device intended to quantitatively measure ferritin (an iron-storage protein) in human serum. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency. This diagnostic method is not intended for use on any other diagnostic system. This in viro method is intended to quantitatively measure hCG, human chorionic gonadotropin, in human serum using ADVIA hCG Assay on a Bayer ADVIA® Integrated Modular System. Measurements of hCG are used in the detection of pregnancy. This diagnostic method is not intended for use on any other diagnostic system. This in viro method is intended to quantitatively measure TSH, Thyroid Stimulating Hormone, in human serum using ADVIA 3d Generation TSH Assay on a Bayer ADVIA® Integrated Modular System. This assay allows the determination of TSH with 3d generation sensitivity of less than 20% total coefficient of variation (CV) at 0.02 µIU/mL, as defined by the American Thyroid Association. Measurements thyroid stimulating hormone are used in the diagnosis of thyroid or pituitary disorders. This diagnostic method is not intended for use on any other diagnostic system.

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