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The TROP method is used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to quantitatively measure cardiac troponin-1 in human serum and plasma. Measurements of TROP aid in the diagnosis of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

The TROP method is a one-step enzyme immunoassay. Sample is incubated with chromium dioxide particles (CrOz) coated with a monoclonal antibody specific for cardiac troponin-1 and conjugate reagent [alkaline phosphatase (ALP) labeled monoclonal antibody specific for cardiac troponin-I] to form a particle/cardiac troponin-I/conjugate sandwich. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound ALP initiates an amplification cascade. ALP dephosphorylates synthetic flavin adenine dinucleotide phosphate (FADP) to give FAD. FAD binds to APO D-amino acid oxidase and converts it to active holo D-amino acid oxidase. Each molecule of holo D-amino acid oxidase then produces multiple molecules of hydrogen peroxide (H2O2), which in the presence of horseradish peroxidase (HRP), converts 3,5-dichloro-2-hydroxybenzenesulfonic acid (DCHBS) and 4-aminoantipvrine (4-AAP) to a colored product that absorbs at 510nm. The color measured is directly proportional to the concentration of cardiac troponin-I present in the patient sample.

The PSA Control is an in vitro diagnostic product intended to be used as a quality control product for the Prostate Specific Antigen (PSA) method on the aca® plus immunoassay system and Dimension® clinical chemistry system with the heterogeneous immunoassay module.

PSA Control is a frozen product containing human PSA-ACT in a bovine serum albumin base. The kit consists of twelve vials, six at each of two levels, containing 5 mL each.

The PSA Calibrator is an in vitro diagnostic product intended to be used to calibrate the Prostate Specific Antigen (PSA) method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassy module. This product was designed to meet the needs of users to assure accurate results over the assay range of this method.

Prostate Specific Antigen (PSA) Calibrator for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module is a frozen product. The Level 1 calibrator is horse serum based with no detectable PSA. Levels 2 through 5 contain human PSA-ACT in a bovine serum albumin base. The kit consists of ten vials; two at each of five levels, containing 1 mL each.

The PSA method for the Dimension® RxL with the heterogeneous immunoassay module is a device used to measure PSA in serum as an aid in the management of prostate cancer patients.

The PSA method is a one-step enzyme immunoassay. Sample is incubated with chromium dioxide particles (CrO2) coated with monoclonal antibodies specific for a binding site on the PSA molecule and conjugate reagent [β-galactosidase (β-gal) labeled monoclonal antibodies specific for a second binding site on the PSA molecule] to form a particle/PSA/conjugate sandwich. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound ß-gal catalyzes the hydrolysis of chlorophenol red-β-d galactopyranoside (CPRG) to chlorophenol red (CPR). The color change measured at 577nm due to the formation of CPR is directly proportional to the concentration of PSA present in the patient sample.

The FT4 Method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module is used to quantitatively measure free thyroxine (FT4) in human serum and heparinized plasma.

The FT4 assay is a two-step competitive enzyme immunoassay. Sample is incubated with chromium dioxide particles, coated with monoclonal antibodies specific for FT4 to form a particle/T4 complex. Particles are separated magnetically and the supernatant removed. The particle/T4 complex is incubated with conjugate reagent to react with unoccupied binding sites on the particles. Unbound conjugate is removed by washing. The bound alkaline phosphatase triggers an amplification cascade, resulting in the formation of a colored product. The color change measured at 510nm is inversely proportional to the concentration of free thyroxine present in the patient sample.

The HCG method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module is used to quantitatively measure intact hCG in serum and plasma, for the early detection of pregnancy.

The HCG method for the Dimension® RxL system with the heterogeneous immunoassay module is a two-step enzyme immunoassay based on the "sandwich" principle. Sample is incubated with chromium dioxide particles coated with monoclonal antibodies specific for the hCG alpha subunit to form a particle/hCG complex. Particles are separated magnetically and the supernatant removed. The particle/hCG complex is incubated with conjugate reagent (β-galactosidase labeled monoclonal antibodies specific for the hCG beta subunit) to form a particle/hCG/conjugate sandwich. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound ß-galactosidase is combined with the chromogenic substrate chlorophenol red-ß-d-galactopyranoside (CPRG) and catalyzes the hydrolysis of CPRG to the chromophore chlorophenol red (CPR). The concentration of hCG in the patient sample is directly proportional to the rate of color change measured at 577nm due to formation of CPR.

The MMB Calibrator is intended to be used to calibrate the MMB method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.

The MMB Calibrator is a lyophilized horse serum-based product. The Level 1 calibrator contains no detectable CKMB. Levels 2 through 5 contain human CKMB. The kit consists of ten vials; two at each of five levels.

The TSH method is used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to quantitatively measure TSH in human serum and plasma. Measurements of TSH aid in the diagnosis of thyroid or pituitary disorders.

The TSH method is a one-step enzyme immunoassay. Sample is incubated with chromium dioxide particles (CrO2) coated with monoclonal antibodies specific for the intact TSH molecule and conjugate reagent [alkaline phosphatase (ALP) labeled monoclonal antibodies specific for the TSH beta subunit] to form a particle/TSH/conjugate sandwich. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound ALP initiates an amplification cascade. ALP dephosphorylates synthetic flavin adenine dinucleotide phosphate (FADP) to give FAD. FAD binds to APO d-amino acid oxidase and converts it to active holo d-amino acid oxidase. Each molecule of holo d-amino acid oxidase then produces multiple molecules of hydrogen peroxide (H2O2), which in the presence of horseradish peroxidase (HRP), converts 3,5-dichloro-2-hydroxybenzenesulfonic acid (DCHBS) and 4-aminoantipyrine (4-AAP) to a colored product that absorbs at 510nm. The color measured is directly proportional to the concentration of TSH present in the patient sample.

The HCG Calibrator is intended to be used to calibrate the HCG method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.

The Human Chorionic Gonadotropin (HCG) Calibrator for the Dimension® RxL system is a lyophilized horse serum-based product. The Level 1 calibrator contains no detectable hCG. Levels 2 through 5 contain human unne chorionic gonadotropin. The kit consists of ten vials; two at each of five levels.

The Thyroid Calibrator is intended to be used on the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module to calibrate the FT4 and TSH methods.

The Thyroid Calibrator is a liquid bovine albumin based product. The Level 1 calibrator contains no detectable thyroxine or TSH. Levels 2 through 5 contain thyroxine and human TSH. The kit consists of ten vials; two at each of five levels.