Search Results

The Tacrolimus Assay Kit is used for quantitative determination of the tacrolimus concentration in human whole blood on the Beckman Coulter AU480. It is to be used as an aid in the management of liver and kidney allograft patients receiving tacrolimus therapy. For In Vitro Diagnostic Use.

The Tacrolimus Assay Kit utilizes the latex-enhanced competitive immunoturbidimetry method for quantitative determination of the tacrolimus concentration in human whole blood. The assay consists of reagents, sample extract and calibrator.

Immunoassay for the in vitro quantitative determination of tacrolimus in EDTA human whole blood. The assay is used as an aid in the management of liver and kidney transplant patients receiving tacrolimus therapy. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.

The Elecsys Tacrolimus immunoassay uses the principle of electrochemiluminescence for detection and measurement. Before testing with the Elecsys Tacrolimus assay, the specimen, calibrators and controls are pretreated with the Elecsys ISD Pretreatment Reagent. The reagent lyses the cells, extracts Tacrolimus and precipitates virtually all of the blood proteins. The pretreated samples are centrifuged, and an aliquot of the resulting supernatant containing Tacrolimus is then assayed using the Elecsys Tacrolimus assay. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode.

The Dimension Tacrolimus Flex® Reagent Cartridge (TAC) is an in vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension® clinical chemistry system. Measurements of tacrolimus are used as an aid in the management of tacrolimus therapy in renal and hepatic transplant patients. The Dimension Tacrolimus Callbrator (TAC CAL) is an in vitro diagnostic product for the Tacrolimus (TAC) method on the Dimension® clinical chemistry system.

The automated Dimension® TAC method uses an immunoassay technique in which free and tacrolimus-bound antibody-enzyme conjugate is separated using magnetic particles. The assay is performed using a method specific Flex® reagent cartridge. The Flex® cartridge contains a pretreatment reagent, antibody-ß-galactosidase conjugate, tacrolimus immobilized on chromium dioxide particles, chlorophenol red ß-d-galactopyranoside (CPRG) substrate, and diluent to hydrate the tablets. Dimension® Tacrolimus (TAC) Calibrator is five level frozen liquid, whole blood hemolysate containing purified tacrolimus. The provided in 4.0 mL vials, 2 vials per level. There are five calibrator levels per kit which span the assay range for the Dimension® Tacrolimus (TAC) assay. Calibrators are filled with 1.0 mL per vial except for Level 1 calibrator which contains 2.0 mL per vial.

The QMS® Tacrolimus Immunoassay is intended for the quantitative determination of tacrolimus in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney, liver, and heart transplant patients receiving tacrolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only. The QMS® Tacrolimus Calibrator set is intended for use in calibration of the QMS® Tacrolimus Immunoassay.

The QMS® Tacrolimus Immunoassay consists of separately packaged reagents (Reagent 1, Reagent 2 and Extraction Reagent) and calibrators (Calibrator A, B, C, D, E, and F). Reagent 1 (Antibody Reagent): <1.0% Anti-Tacrolimus monoclonal antibody (rabbit) in a buffer as stabilizer and <0.09% sodium azide as preservative. Configuration: 1 x 18 mL. Reagent 2 (Microparticle Reagent): <0.3% Tacrolimus-coated microparticles in buffer containing <0.09% sodium azide as preservative. Configuration: 1 x 12 mL. Extraction Reagent: 300 mM Zinc Sulfate and <0.09% sodium azide as preservative. Configuration: 1 x 50 mL. QMS® Tacrolimus Reagents are provided ready-to-use in liquid form and are to be stored at 2 to 8°C until the expiration date on the label. Calibrator Level, Target Concentration (ng/mL), Configuration: Calibrator A, 0.0, 1 x 4 mL Calibrator B, 2.0, 1 x 2 mL Calibrator C, 5.0, 1 x 2 mL Calibrator D, 10.0, 1 x 2 mL Calibrator E, 20.0, 1 x 2 mL Calibrator F, 30.0, 1 x 2 mL The QMS® Tacrolimus Calibrator kit is provided separately and packaged in amber glass bottles in a rectangular cardboard box with a 6-bottle divider. The calibrators are provided in liquid form and are to be stored at -20℃ ± 5℃ until the expiration date on the label. They are ready-to-use upon thawing.

The ARCHITECT Tacrolimus assay is a chemiluminescent Microparticle immunoassay (CMIA) for the quantitative determination of tacrolimus in human whole blood on the ARCHITECT i System. The ARCHITECT Tacrolimus assay is to be used as an aid in the management of liver and kidney allograft patients receiving tacrolimus therapy. The ARCHITECT Tacrolimus Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of tacrolimus in human whole blood. The ARCHITECT Tacrolimus Whole Blood Precipitation Reagent is for the extraction of tacrolimus from samples (human whole blood patient specimens, controls, and ARCHITECT Tacrolimus Calibrators) to be tested on the ARCHITECT i System.

The ARCHITECT Tacrolimus assay is a delayed one-step immunoassay for the quantitative determination of tacrolimus in human whole blood using CMIA technology with flexible assay protocols, referred to as Chemiflex. Prior to the initiation of the automated ARCHITECT sequence, a manual pretreatment step is performed in which the whole blood sample is extracted with a precipitation reagent and centrifyged. The supernatant is decanted into a Transplant Pretreatment Tube, which is placed onto the ARCHITECT i System. Sample, assay diluent, and anti-tacrolimus coated paramagnetic microparticles are combined to create a reaction mixture. Tacrolimus present in the sample binds to the anti-tacrolimus coated microparticles. After a delay, tacrolimus acridinium-labeled conjugate is added to the reaction mixture. The tacrolimus on the acridinium-labeled conjugate competes for the available binding sites on the microparticles. Following an incubation, the microparticles are washed, and pretrigger 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 tacrolimus in the RLUs detected by the ARCHITECT i System optics.

The Waters MassTrak Immunosuppressants Kit is indicated for the quantification of the immunosuppressive drug Tacrolimus (FK506; Prograf) in liver and kidney transplant patient whole blood samples for the purposes of monitoring drug levels to direct subsequent patient dosing.

The MassTrak Immunosuppressants Kit for Tacrolimus is an in vitro medical device intended to facilitate quantitative determination of Tacrolimus in human whole blood as an aid in the management of kidney and liver transplant patients receiving Tacrolimus drug therapy. The components of the kit are intended for use with an LC/MS/MS system. The kit materials - calibrators, quality control materials, internal standards, and neat solutions, as well as a MassTrakTM 2.1 x 10 mm C18 cartridge column - have been optimized for use with the Waters Quattro micro and Alliance 2795 System, but can be used with any LC/MS/MS configuration optimized for quantification.

The Dimension® TACR Flex® reagent cartridge is an in vitro diagnostic test intended to quantitatively measure tacrolimus in human whole blood on the Dimension® clinical chemistry system. Measurements of tacrolimus are used as an aid in the management of tacrolimus therapy in kidney and liver transplant patients.

The Dimension® TACR Flex® reagent cartridge is an in vitro diagnostic device that consists of prepackaged reagents in a plastic eight-well cartridge for use on the Dade Behring Dimension® clinical chemistry system.

The Emit® 2000 Tacrolimus Assay is for in vitro quantitative analysis of tacrolimus and metabolite in human whole blood as an aid in the management of tacrolimus therapy in liver and kidney transplant patients. The Emit® 2000 Tacrolimus Sample Pretreatment Reagent is an accessory reagent for use with the Emit® 2000 Tacrolimus Assay.

The Emit® 2000 Tacrolimus Assay is for in vitro diagnostic use for the quantitative analysis of tacrolimus and metabolite in human whole blood as an aid in the management of tacrolimus therapy in liver and kidney transplant patients. The Emit® 2000 Tacrolimus Assay is comprised of an antibody reagent, a buffer reagent and an enzyme reagent. This assay contains mouse monoclonal antibodies with a high specificity for tacrolimus. The Emit® 2000 Tacrolimus Sample Pretreatment Reagent is an accessory reagent for use with the Emit® 2000 Tacrolimus Assay. The Emit® 2000 Tacrolimus Sample Pretreatment Reagent is used to pretreat the whole blood samples, calibrators, and controls prior to testing with the Emit® 2000 Tacrolimus Assay. The pretreatment process lyses the cells, extracts the tacrolimus, and precipitates most of the blood proteins. The pretreated samples are centrifuged, and an aliquot of the resulting supernatant containing tacrolimus is then assayed using the Emit® 2000 Tacrolimus Assay.

The CEDIA® Tacrolimus Assay is an in vitro diagnostic medical device intended for the quantitative determination of tacrolimus in human whole blood using automated clinical chemistry analyzers as an aid in the management of kidney and liver transplant recipients receiving tacrolimus therapy. CEDIA® Tacrolimus Calibrators are intended for calibration of the CEDIA® Tacrolimus Assay in whole blood.

The CEDIA® Tacrolimus Assay uses recombinant DNA technology (US Patent No. 4708929) to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ß-galactosidase, which has been genetically engineered into two inactive fragments i.e., enzyme acceptor (EA) and enzyme donor (ED). These fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically. In the assay, analyte in the sample competes with analyte conjugated to one inactive fragment (ED) of ß-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the reassociation of inactive ß-galactosidase fragments, and no active enzyme is formed. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of analyte present in the sample.