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For in vitro diagnostic and laboratory professional use. VITROS Chemistry Products PHBR Slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma (lithium heparin) using the automated VITROS 5600 Integrated System. Measurements obtained by this device are used as an aid in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital to help ensure appropriate therapy.

The VITROS PHBR Slide is a multilayered, analytical element coated on a polyester support. The phenobarbital assay is based on an enzymatic heterogeneous, competitive immunoassay format. Immobilized anti-phenobarbital antibody and phenobarbital-peroxidase conjugate are present in the spreading layer. A drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. Phenobarbital in the sample competes with the phenobarbitalperoxidase conjugate for a limited number of antibody binding sites during Incubation 1. The subsequent addition of 12 µL of VITROS Immuno-Wash Fluid to the slide removes unbound phenobarbital-peroxidase conjugate from the read area, while also providing a substrate for the enzyme mediated oxidation of leuco dye. The rate of dye formation, as monitored by reflectance spectrophotometry for Incubation 2, is inversely proportional to the phenobarbital concentration in the sample. To determine if an adequate wash has occurred, a wash detection dye is read at 540 nm during Incubation 2.

The Abbott Phenobarbital assay is for in vitro diagnostic use for the quantitative measurement of phenobarbital in human serum or plasma on the ARCHITECT cSystems. The measurements obtained are used in the diagnosis and treatment of phenobarbital overdose and in monitoring levels of phenobarbital to help ensure appropriate therapy.

The Phenobarbital Assay kit is supplied ready-to-use in liquid form, for storage at 2 to 8°C. Each Phenobarbital Assay kit is packaged in a rectangular cardboard box divided into three sections. One section will contain three bottles of Antibody Reagent (R1), one section will contain three bottles of Microparticle Reagent (R2), and the last section will contain the package insert. Each kit is sufficient for 300 tests.

The ARCHITECT iPhenobarbital assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of phenobarbital, an anticonvulsant and sedative-hypnotic drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in the diagnosis and treatment of phenobarbital overdose and in monitoring levels of phenobarbital to help ensure appropriate therapy. The ARCHITECT iPhenobarbital Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of phenobarbital in human serum or plasma.

The ARCHITECT i Phenobarbital assay is a one-step STAT immunoassay for the quantitative measurement of phenobarbital in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex. Sample, antiphenobarbital coated paramagnetic microparticles, and phenobarbital acridiniumlabeled conjugate are combined to create a reaction mixture. The anti-phenobarbital coated microparticles bind to phenobarbital present in the sample and to the phenobarbital acridinium-labeled conjugate. After washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of phenobarbital in the sample and the RLUs detected by the ARCHITECT i System optics.

The ONLINE TDM Phenobarbital assay is for the quantitative determination of phenobarbital in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital.

The ONLINE TDM Phenobarbital assay is for the quantitative determination of phenobarbital in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of phenobarbital use or overdose and in monitoring levels of phenobarbital. The proposed labeling indicates the Roche Hitachi 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM Phenobarbital reagent kits.

The Abbott Aeroset® Phenobarbital Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of phenobarbital in human serum or plasma on the Abbott Aeroset® analyzer (K980367). Monitoring serum phenobarbital concentrations, along with careful clinical assessment, is the most effective means of improving seizure control, reducing the risk of toxicity, and minimizing the need for additional anticonvulsant medication for the following reasons (1-3): - Serum phenobarbital concentrations correlate better with concentration in the brain than does dosage once steady state is reached. - Patients taking the same dosage of phenobarbital show considerable variation in serum phenobarbital concentrations because of individual differences in absorption, metabolism, disease states, and compliance. Serum level monitoring helps physicians individualize dosage regimens. Methods historically used to monitor serum phenobarbital concentrations are gas-liquid chromatography, high-performance liquid chromatography, radioimmunoassay, and immunoassay (1,2).

The Abbott Aeroset™ Phenobarbital Assay is a homogenous enzyme assay intended for use in quantitative analysis of phenobarbital in human serum or plasma.

For in vitro diagnostic use only. VITROS PHBR slides quantitatively measure phenobarbital (PHBR) concentration in serum and plasma.

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