Lipoprotein reagent kit LDL-30 series

enzymefor biochemistrydiagnostic

This reagent is intended for the in vitro quantitative determination of low-density lipoprotein cholesterol (LDL-C) in human serum. METHODOLOGY The assay is based on a modified polyvinyl sulfonic acid (PVS) and polyethylene-glycol methyl ether (PEGME) coupled classic precipitation method with the improvements in using optimized quantities of PVS/PEGME and selected detergents. LDL, VLDL, and chylomicron (CM) react with PVS and PEGME and the reaction results in inaccessibility of LDL, VLDL and CM by cholesterol oxidase (CHOD) and cholesterol esterase (CHER), whereas HDL reacts with the enzymes. Addition of R2 containing a specific detergent releases LDL from the PVS/PEGME complex. The released LDL reacts with the enzymes to produce H2O2 which is quantified by the Trinder reaction. REAGENT COMPOSITION Reagent 1: MES buffer (pH 6.5), Polyvinyl sulfonic acid, 4-aminoantipyrine, Cholesterol esterase, Cholesterol oxidase, Peroxidase, Polyethylene-glycol-methyl ester, MgCI2, Detergent, EDTA Reagent 2: MES buffer (pH 6.5), TODB N,N-Bis(4-sulfobutyl)-3- methylaniline, Detergent, EDTA REAGENT PREPARATION Reagent 1 and Reagent 2 are ready to use. Precautions and Warnings: 1. For in vitro diagnostic use only. 2. DO NOT pipette by mouth. 3. Avoid contact with skin and eyes. If spilt, thoroughly, wash affected areas with water. 4. All specimens used in the test should be considered potentially infectious. 5. Do not use the reagent after the expiration date printed on the kit. REAGENT DETERIORATION: Do Not Use Reagent If: 1. The reagent develops turbidity. 2. The reagent fails to recover control values within the assigned range.