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The SPIFE Lipoprotein-12 System is intended for the separation and quantitation of serum or plasma lipoproteins used in the diagnosis and treatment of lipid disorders, atherosclerosis, and various liver and renal diseases.

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The HYDRAGEL 7 LIPOPROTEIN(E) and HYDRAGEL LIPOPROTEIN(E) 15/30 kits are designed for determination of lipoprotein profiles in human serum. They all utilize the same composition of alkaline buffered agarose gels, same reagents and the same procedure. They are all designed for use with the semi-automated HYDRASYS electrophoresis apparatus. The only differences among the individual kits are the intended number of samples per gel: 7, 15 or 30 samples. The assay is carried out in two stages: · electrophoresis on agarose gel to separate the VLDL, LDL and HDL as well as chylomicrons when present. · visualization of lipoprotein fractions with a lipid specific Sudan black stain; the excess of stain is removed with an alcoholic solution. The resulting electrophoregrams can be evaluated visually for pattern abnormalities or by densitometry to obtain approximate, relative quantification of individual zones. Fredrickson classification of lipoproteins aids in the interpretation of lipoprotein patterns. Both the qualitative (presence of abnormal or absence of normal fractions) and semi-quantitative (relative increase or decrease of fractions) abnormalities necessitate further lipoprotein analyses. The procedure is indicated for the general population for determination of lipoprotein profiles.

The HYDRAGEL 7 LIPOPROTEIN(E) and HYDRAGEL LIPOPROTEIN(E) 15/30 kits are designed for determination of lipoprotein profiles in human serum. They all utilize the same composition of alkaline buffered agarose gels, same reagents and the same procedure. They are all designed for use with the semi-automated HYDRASYS electrophoresis apparatus. The only differences among the individual kits are the intended number of samples per gel: 7, 15 or 30 samples. The assay is carried out in two stages: · electrophoresis on agarose gel to separate the VLDL, LDL and HDL as well as chylomicrons when present. · visualization of lipoprotein fractions with a lipid specific Sudan black stain; the excess of stain is removed with an alcoholic solution. The resulting electrophoregrams can be evaluated visually for pattern abnormalities or by densitometry to obtain approximate, relative quantification of individual zones. Fredrickson classification of lipoproteins aids in the interpretation of lipoprotein patterns.

The Quantimetrix Lipoprint™ System LDL Subfractions is a device intended to measure lipoprotein cholesterol (for lipoprotein fractions and subfractions) in fasting serum or plasma with a Total Cholesterol concentration of ≥ 100 mg/dl. Lipoprotein cholesterol measurements are used as an aid in evaluating lipid metabolism disorders when used in conjunction with other lipid tests, patient risk assessment and clinical evaluation.

Quantimetrix is implementing an analysis software capability to the LipoPrint™ System LDL Subfractions. The software application is used in conjunction with commercially available hardware (computer, scanner and color printer) to analyze scanned tube images and generate characterizations of lipoprotein fractions and subfractions resolved by Lipoprint (VLDL, IDL, LDL, HDL).

HYDRAGEL LDLIHDL CHOL Direct K20, HYDRAGEL 7 LDLIHDL CHOL Direct and HYDRAGEL LDLHDL CHOL Direct 15/30 kits are designed for quantification of the cholesterol canied by the Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) fractions of human serum. The analysis is performed in two stages: · electrophoresis on agarose get to separate the VLDL, LDL and HDL as well as chylomicrons, · visualization of lipoprotein fractions based on a sensitive and cholesterol-specific enzymatic procedure involving the cholesterol esterase / cholesterol dehydrogenase system coupled with nitro blue tetrazolium chromogen. The stained electrophoregrams are intended for visual interpretation to confirm identification of the individual fractions and for densitometry to obtain relative concentrations of cholesterol in the individual lipoprotein fractions. When the sample's total cholesterol value is known, cholesterol distribution in a/dL or mol/L concentrations can be calculated. The test system is intended for the measurement of the LDL cholesterol and HDL cholesterol. The cholesterol values of only these two fractions are indicated as an aid in the diagnosis and treatment of lipid disorders. The procedure is indicated for the general population for a direct measurement of: - . the LDL cholestero! level regardless the triglyceride levels - the HDL cholesterol level . - the ratio LDL/HDL cholesterol . The HYDRAGEL LDUHDL CHOL Direct K20 kit is designed for use with a manual electrophoresis apparatus, K20. The kit is intended to run up to 7 samples per gel. The HYDRAGEL 7 LDL/HDL CHOL Direct and HYDRAGEL LDL/HDL CHOL Direct 15/30 kits are designed for use with the semi-automated Hydrasys electrophoresis apparatus. These kits are intended to run up to 7, 15 and 30 samples per gel, respectively.

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The SPIFE 2000/3000 Lipoprotein System is useful in the prevention of coronary heart disease. Increased dietary fats and cholesterol are associated with atherosclerosis which leads to cardiovascular disease and strokes.

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The Cholesterol Profile test system is useful in monitoring LDL, VIDI, and Lp(a)-C cholesterol when present in concentrations HDL. However in some patients Lp(a)-C may not be greater than 2.5 mg/dL. present at concentrations detectable by electrophoresis. Patients at risk include males over the age of 45 years and females over 55 years, those with family history of coronary heart disease, strokes, hypertension or diabetes and those who smoke. Depending on a patient's number of risk factors, treatment can be medication or diet restrictions.

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The HYDRAGEL-MINI LIPO, HYDRAGEL LIPO, HYDRAGEL LIPO MAXI, HYDRAGEL, 7 LIPO, and HYDRAGEL 15/30 LIPO kits are designed for determination of lipoprotein profiles in human serum.

All HYDRAGEL LIPO kits utilize the same composition of alkaline buffered HYDRAGEL LIPO agarose gels, same reagents and the same procedure. The only differences among the individual kits are the number of samples per gel and that some kits are for the manual and some for the automated format: The HYDRAGEL-MINI LIPO , HYDRAGEL LIPO and HYDRAGEL LIPO MAXI kits are designed for use with a manual electrophoresis apparatus. These kits are intended to run up to 5, 8 and 10 samples per gel, respectively. The HYDRAGEL 7 LIPO and HYDRAGEL 15/30 LIPO kits are designed for use with the semiautomated Hydrasys electrophoresis apparatus. These kits are intended to run up to 7, 15 and 30 samples per gel, respectively, The resulting electrophoregrams can be evaluated visually for pattern abnormalities or by densitometry to obtain approximate, relative quantification of individual zones. Fredrickson classification of lipoproteins aids in the interpretation of lipoprotein patterns. Indication of the qualitative (presence of abnormal or absence of normal fractions) or semi-quantitative (relative increase or decrease of fractions) abnormalities necessitates further lipoprotein analyses.

The Cholesterol test system is useful in monitoring LDL and HDL cholesterol levels. Patients at risk include males over 45 years and females over 55 years, those with family history of coronary heart disease, strokes, hypertension or diabetes and those who smoke. Depending on a patients' number of risk factors, treatment can be medication or diet restrictions.

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