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The s LDL-EX"SEIKEN" test is for the quantitative determination of small, dense (sd) LDL cholesterol (-C) in human serum or plasma. The s LDL-EX"SEIKEN" test is used in conjunction with other lipid measurements and clinical evaluations to aid in the risk management of lipoprotein disorders associated with cardiovascular disease.

The assay consists of two steps and is based on the technique to use well-characterized surfactants and enzymes that selectively react with certain groups of lipoproteins. In the first step, non-sd LDL lipoproteins, that is, chylomicrons, VLDL, IDL, L-LDL and HDL are decomposed by a surfactant and sphingomyelinase in Reagent-1 that is reactive to those non-sd LDL lipoproteins. The cholesterol released from such non-sd LDL lipoproteins is then degraded to water and oxygen by the action of enzymes. Cholesterol ester is hydrolyzed by the cholesterol esterase (CHE) and then oxidized by the cholesterol oxidase (CO). Produced hydrogen peroxides are finally decomposed to water and oxygen by the catalase. In the second step, another surfactant in Reagent-2 releases cholesterol only from sd LDL particles and cholesterol released from sd LDL is then subject to the enzymatic reactions. As catalase in the reaction mixture is inhibited by sodium azide in Reagent-2, hydrogen peroxides, produced from the reaction with the cholesterol esterase and cholesterol oxidase, develop a purple-red color with the coupler in the presence of peroxidase (POD).

The ARCHITECT® Insulin Calibrators are for the calibration of the ARCHTECT® i System when used for the quantitative determination of human insulin in human serum and plasma. The ARCHITECT® Insulin Controls are for the verification of the accuracy and precision of the ARCHITECT® i System when used for the quantitative determination of human insulin in human serum or plasma.

The ARCHITECT® Insulin Calibrators are for the calibration of the ARCHITECT® i System when used for the quantitative determination of human insulin in human serum and plasma. The ARCHITECT® Insulin Controls are for the verification of the accuracy and precision of the ARCHITECT® i System when used for the quantitative determination of human insulin in human serum and plasma.

The LDL-EX SEIKEN Assay Kit is an in vitro diagnostic test for the quantitative determination of low-density lipoprotein cholesterol (LDL-C) in human serum and heparinized- or EDTA-plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus, atherosclerosis and various liver and renal diseases). The device is intended to be used on automated chemistry analyzers in clinical laboratories.

The LDL-EX SEIKEN Assay Kit is an in vitro diagnostic test for the quantitative determination of low-density lipoprotein cholesterol (LDL-C) in human serum and heparinized- or EDTA-plasma on automated chemistry analyzers. The LDL-EX SEIKEN Assay Kit is a homogeneous method for directly measuring LDL-C levels in serum and plasma without the need for any off-line pretreatment or centrifugation steps.

The HDL-EX SEIKEN Assay Kit is an in vitro diagnostic test for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum and heparinized- or EDTA-plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus, atherosclerosis and various liver and renal diseases). The device is intended to be used on automated chemistry analyzers in clinical laboratories.

The HDL-EX SEIKEN Assay Kit is an in vitro diagnostic test for the quantitative determination of high-density lipoprotein cholesterol (HDL-C) in human serum and heparinized- or EDTA-plasma on automated chemistry analyzers. The HDL-EX SEIKEN Assay is a homogeneous method for directly measuring HDL-C levels in serum and plasma without the need for any off-line pretreatment or centrifugation steps.

The CRP-Latex (II)X2 SEIKEN Assay kit is an in vitro diagnostic test for the quantitative determination of C-reactive protein in human serum and lithium heparin or EDTA plasma samples by immunoturbidimetry. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury and inflammatory disorders.

The CRP-Latex (II)X2 SEIKEN Assay Kit is a latex in vitro diagnostic immunoassay for the quantitative determination of C-reactive protein in human serum and in heparinized and EDTA-plasma. Antigen in the sample bonds to the specific anti-CRP antibody, which has been adsorbed to latex particles, and agglutinates. The agglutination is detected as an absorbance change when read on an automated chemistry analyzer (the Hitachi 917 was used for these studies), with the magnitude of the change being proportional to the quantity of CRP in the sample. The actual concentration is then determined by interpolation from a calibration curve prepared from calibrators of known concentration.

The CRP(II) Calibrators are intended to be used for the calibration of the CRP-Latex (II)X2 SEIKEN Assay kit for quantitating CRP (C-reactive protein) in human serum and EDTA or lithium heparinized plasma samples.

The CRP(II) Calibrator is intended to be used for the calibration of the CRP-Latex(II)X2 SEIKEN