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The Seradyn QMS® Topiramate assay is intended for the quantitative determination of topiramate in human serum or plasma on automated clinical chemistry analyzers. The results obtained are used in the diagnosis and treatment of topiramate overdose and in monitoring levels of topiramate to help ensure appropriate therapy.

The Seradyn QMS® Topiramate assay is a homogeneous particle-enhanced turbidimetric immunoassay. The assay is based on competition between drug in the sample and drug coated onto a micronariticle for antibody binding sites of the topiramate antibody reagent. The topiramate-coated micropariticle peagent is rapidly agglutinated in the presence of the anti-topiramate antibody reagent and in the abserved of any competing drug in the sample. The rate of absorbance change is measured photometrically. When a smale containing topiramate is added, the agglutination reaction is partially inhibited, slowing down the rate of absorbance change. A concentration-dependent classic agglutination inhibition curve can be obtained with maximum rate of agglutination at the lowest topiramate concentration and the lowest agglutination rate at the highest topiramate concentration. The assay consists of reagents R1: anti-topiramate polyclonal antibody and R2: topiramate-ooated microparticles. A six-level set of Seradyn QMS® Topiramate Cali three-level set of Seradyn QMS® Topiramate Controls is used for quality control of the assay.

The QMS® Lamotrigine assay is intended for the quantitative determination of lamotrigine in human serum or plasma on automated clinical chemistry analyzers. Lamotrigine concentrations can be used as an aid in management of patients treated with lamotrigine. The QMS® Lamotrigine Calibrator set is intended for use in calibration of the QMS Lamotrigine assay. The QMS® Lamotrigine Control set is intended for use in quality control of the QMS Lamotrigine assay.

The QMS Lamotrigine assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle. The assay consists of reagents R1: anti-Lamotrigine sheep polyclonal antibody and R2: Lamotriginecoated microparticles. A six-level set of QMS Lamotrigine Calibrators (A through F) is used to calibrate the assay. A three-level set of QMS Lamotrigine Controls (1 thro the assay.

ARCHITECT® Cortisol is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cortisol in human serum, plasma or urine on the ARCHITECT i System. The ARCHITECT Cortisol assay is intended for use as an aid in the diagnosis and treatment of adrenal disorders. The ARCHITECT Cortisol Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of cortisol in human serum, plasma or urine.

The ARCHITECT Cortisol assay is a delayed one-step immunoassay for the quantitative determination of cortisol in human serum, plasma or urine using CMIA technology with flexible assay protocols, referred to as Chemiflex®.

The Multigent® Gentamicin assay is intended for the quantitative determination of Gentamicin in human serum or plasma on the Architect C8000 System. The results obtained are used in the diagnosis and treatment of Gentamicin overdose and in monitoring levels of Gentamicin to ensure appropriate therapy.

The Multigente Gentamicin assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle. The assay consists of reagents R1: anti-gentamicin monoclonal antibody and R2: gentamicin-coated microparticles. A six-level set of Multigent" Gentamicin Calibrators (A through F) is used to calibrate the assay.

The QMS® Quinidine assay is intended for the quantitative determination of quinidine in human serum or plasma on automated clinical chemistry analyzers. The results obtained are used in the diagnosis and treatment of quinidine overdose and in monitoring levels of quinidine to help ensure appropriate therapy.

The QMS® Quinidine assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle. In particle agglutination assays, the degree of agglutination is inversely proportional to the quantity of free drug in the reaction well. Hence, if no drug is present in the sample, the antibodies in the QMS® Quinidine Antibody Reagent (R1) will bind only to the bound drug on the particle which will cause it to agglutinate and will result in higher absorbance. If increased amount of competing drug is present in the sample, this will result in decreased binding of bound drug by the antibody, resulting in a relative decrease in particle agglutination. This in turn results in lower absorbance. The precise relationship between particle agglutination of the unlabeled drug in the sample is established by measuring the absorbance values of calibrators with known concentration of the The absorbance of unknown samples can be interpolated from the absorbance values of the drug, calibration curve and the concentration of the drug present in the sample can be calculated. The assay consists of reagents R1: anti-quinidine monoconal and R2: quinidine-oated microparticles. A six-level set of QMS® Quinidine Calibrators (A throu

The QMS Zonisamide assay is intended for the quantitative determination of zonisamide in human serum or plasma on automated clinical chemistry analyzers. Zonisamide concentrations can be used as an aid in management of patients treated with zonisamide. The QMS® Zonisamide Calibrator set is intended for use in calibration of the QMS Zonisamide assay. The QMS® Zonisamide Control set is intended for use in quality control of the QMS Zonisamide assay.

The QMS Zonisamide assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle. The assay consists of reagents R1: anti-Zonisamide rabbit polyclonal antibody and R2: Zonisamidecoated microparticles. A six-level set of QMS® Zonisamide Calibrators (A through F) is used to calibrate the assay. A three-level set of QMS® Zonisamide Controls (1 through 3) is used for quality control of the assay.

The QMS® Amikacin assay is intended for the quantitative determination of amikacin in human serum or plasma on automated clinical chemistry analyzers. The results obtained are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy.

The QMS® Amikacin assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle. In particle agglutination assays, the degree of agglutination is inversely proportional to the quantity of free drug in the reaction well. Hence, if no drug is present in the sample, the antibodies in the QMS Amikacin Antibody Reagent (R1) will bind only to the bound drug on the particle which will cause it to agglutinate and will result in higher absorbance. If increased amount of competing drug is present in the sample, this will result in decreased binding of bound drug by the antibody, resulting in a relative decrease in particle agglutination. This in turn results in lower absorbance. The precise relationship between particle agglutination of the unlabeled drug in the sample is established by measuring the absorbance values of calibrators with known concentration of the drug. The absorbance of unknown samples can be interpolated from the absorbance values of the calibration curve and the concentration of the drug present in the sample can be calculated. The assay consists of reagents R1: anti-amikacin monoclonal antibody and R2: amikacin-coated microparticles. A six-level set of QMS® Amikacin Calibrators (A through F) is used to calibroothe assay.

The QMS® Vancomycin assay is intended for the quantitative determination of vancomycin in human serum or plasma on the Hitachi 717 analyzer. The results obtained are used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.

The QMS® Vancomycin assay is a homogeneous particle-enhanced turbidimetric immunoassay. The assay is based on competition between drug in the sample and drug coated onto a microparticle for antibody binding sites of the vancomycin antibody reagent. The vancomycin-coated microparticle reagent is rapidly aqglutinated in the presence of the anti-vancomycin antibody reagent and in the absence of any competing drug in the sample. The rate of absorbance change is measured photometrically, and is directly proportional to the rate of agglutination of the particles. When a sample containing vancomycin is added, the agglutination reaction is partially inhibited, slowing down the rate of absorbance change. A concentrationdependent classic agglutination inhibition curve can be obtained, with maximum rate of agglutination at the lowest vancomycin concentration and the lowest agglutination rate at the highest vancomycin concentration. The assay consists of reagents R1: vancomycin monoclonal and R2: vancomycin-coated microparticles. A six-level set of QMS® Vancomycin Calibrators (A through F) i

The MULTIGENT™ Hb A1c assay is used in clinical laboratories for the quantitative in vitro measurement of percent Hb Alc (hemoglobin fraction) in human whole blood on the AEROSET® System and ARCHITECT® c8000™ System. The Hb A1c assay is intended to aid in the monitoring of long-term blood glucose control and compliance in individuals with diabetes mellitus. The MULTIGENT™ Hb A1c assay is not intended for use in diagnosing diabetes mellitus. The MULTIGENT™ Ho A1c Calibrators are intended for in vitro diagnostic use with the AEROSET® System and the ARCHITECT® c8000™ System for the calibration of the assays in the MULTIGENT™ Hb Alc Reagent Kit. The MULTIGENT™ Ho Alc Controls are intended for in vitro diagnostic use with the AEROSET® System and the ARCHITECT® c8000™ System for quality control of the assays in the MULTIGENTTM Hb A1c Reagent Kit.

The Device consists of the MULTIGENT™ Hemoglobin A 1 c Reagents, MULTIGENT™ Hemoglobin Alc Calibrators , and MULTIGENT™ Hemoglobin A 1 c Controls, intended for use on AEROSET® System and ARCHITECT® c8000™ System for determination of stable % HbAlc. The assay consists of two separate concentration measurements, the stable form of glycated hemoglobin (Hb A 1 c) and the total hemoglobin (THb), which are used only to determine the percent Hb Alc. and must not be used individually for diagnostic purposes. The whole blood specimen is pre-treated to lyse the erythrocytes. The hemoglobin is degraded by the proteolytic enzyme, pepsin, to form a hemolysate. Both the THb and the Hb A1c concentrations are determined from the same hemolysate. The concentration of total hemoglobin is determined colorimetrically using a wavelength of 604 mm. The sample's measured absorbance is compared to a two-point calibration curve for total hemoglobin. The concentration of stable Hb Alc is measured immunoturbidimetrically using a microparticle agglutination inhibition method. The Hb A1c antibody reagent (R1) contains specific anti-Hb A 1c mouse monoclonal antibodies coupled to microparticles. The Hb A1c agglutinator reagent (R2) contains several copies of the immunoreactive portion of Hb A1c (hapten), covalently bound to a polymer. In the absence of Hb Alc in the sample, the hapten in the R2 reagent binds with the antibodycoated microparticles in the R1 antibody reagent and results in an increase in the rate of agglutination and results in an increase in measured absorbance. In the presence of HD A Ic in the sample, the Hb Alc competes with the hapten in the R2 reagent for binding sites on the antibody-coated microparticles in the R1 antibody reagent and will slow the rate of agglutination as it competes with the Hb Alc agglutinator for antibody binding sites. The increase in concentration of Hb Alc in the sample is inversely proportional to the rate of agglutination and the measured absorbance. The absorbance is measured using a wavelength of 700 nm. The measured absorbance of the sample is compared to the measured absorbance of known Hb Alc concentrations (g/dL) of a six-level calibration curve, and the concentration of the sample is interpolated. The percent Hb A1c is the Hb A1c /THb ratio, calculated automatically by the AEROSET® System and ARCHITECT® c8000™ System, using a conversion factor to correlate the result with an NGSP-certified method. The calibrators are supplied in liquid form and are ready to use without pretreatment. The controls are supplied in lyophilized form and are to be reconstituted with the supplied reconstitution fluid.