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

The QMS® Everolimus Assay consists of separately packaged reagents (R1, R2, and Precipitation Reagent) with the following contents and configurations. R1 Antibody Reagent: <1.0% Anti-Everolimus polyclonal antibody (rabbit) in a buffer as stabilizer and <0.09% sodium azide as preservative. 1 x 22 mL R2 Microparticle Reagent: <0.6% Everolimus-coated microparticles in buffer containing <0.05% sodium azide as preservative. 1 x 8 mL Precipitation Reagent: Precipitating reagent, and <0.09% sodium azide as preservative. 1 x 8 mL The reagents are supplied ready-to-use in liquid form in plastic HDPE bottles, for storage at 2 to 8°C. The reagent set is sufficient for 100 tests.

The Dimension® Mycophenolic Acid Flex® reagent cartridge is an in vitro diagnostic test for the quantitative measurement of Mycophenolic acid (MPA) in human plasma on the Dimension® clinical chemistry system. Measurements of MPA are used as an aid in the management of mycophenolic acid therapy in renal, hepatic, and cardiac transplant patients. The Dimension® Mycophenolic Acid Calibrator is an in vitro diagnostic product for the calibration of the Mycophenolic Acid method on the Dimension® clinical chemistry system.

The liquid reagents are configured in an eight well "Flex®"; the content of each Flex® well is described in the Instructions for Use. The methodology for the Dimension® MPAT assay is based on a homogenous particle enhanced turbidimetric inhibition immunoassay (PETINIA) technique, which uses a latex particle mycophenolic acid conjugate (PR) and monoclonal mycophenolic acid specific antibody (Ab). Mycophenolic acid present in the sample competes with the mycophenolic acid on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of mycophenolic acid in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 340 nm and 700 nm. The Dimension MPAT Calibrator is used to calibrate the MPAT assay on the Dimension system. The calibrator is a five level aqueous BSA matrix product containing Mycophenolic acid. The typical calibration levels for levels 1 through 5 respectively, are 0.0, 0.7, 2.3, 6.7 and 30.0 µg/mL. Level 1 is a zero level, and can be used to dilute samples that exceed 30 µg/mL.

The QMS® Everolimus assay is intended for the quantitative determination of everolimus, the active ingredient of Zortress®, in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney transplant patients receiving Everolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only. The QMS Everolimus Calibrators set is intended for use in calibration of the QMS Everolimus Assay. The QMS® Everolimus Controls set is intended for use in quality control of the QMS® Everolimus Assay.

The QMS® Everolimus Assay system is a homogeneous assay utilizing particle agglutination technology and competitive binding principles.

The Emit® 2000 Sirolimus Assay is for the in vitro quantitative analysis of sirolimus in human whole blood as an aid in the management of sirolimus therapy in kidney transplant patients. The Emit® 2000 Siro/Tacro Sample Pretreatment Reagent is an accessory reagent for use with the Emit® 2000 Sirolimus Assay and/or the Emit® 2000 Tacrolimus Assay. The Emit® 2000 Sirolimus Calibrators are intended for use in the calibration of the Emit® 2000 Sirolimus Assay.

The Emit® 2000 Sirolimus Assay is for in vitro diagnostic use for the quantitative analysis of sirolimus in human whole blood as an aid in the management of sirolimus therapy in kidney transplant patients. The Emit® 2000 Sirolimus 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 sirolimus. The Emit® 2000 Siro/Tacro Sample Pretreatment Reagent is an accessory reagent for use with the Emit® 2000 Sirolimus Assay. The Emit® 2000 Siro/Tacro Sample Pretreatment Reagent is used to pretreat the whole blood samples, calibrators, and controls prior to testing with the Emit® 2000 Sirolimus Assay. The pretreatment process lyses the cells, extracts the sirolimus, and precipitates most of the blood proteins. The pretreated samples are centrifuged, and an aliquot of the resulting supernatant containing sirolimus is then assayed using the Emit® 2000 Sirolimus Assay. The Emit® 2000 Sirolimus Calibrators are frozen material containing sirolimus in preserved whole blood hemolysate. There are six (6) calibrator levels containing 0, 3, 6, 12, 24 and 36 ng/mL.

The CEDIA Mycophenolic Acid Assay is an in vitro diagnostic medical device intended for the quantitative measurement of mycophenolic acid in human plasma using automated clinical chemistry analyzers as an aid in the management of mycophenolic acid therapy in renal and cardiac transplant patients. The CEDIA Mycophenolic Acid Calibrators are intended for use in the calibration of the CEDIA MPA Assay. The MAS Mycophenolic Acid Controls are intended for use as assayed quality control material for validation of MPA assays.

The CEDIA Mycophenolic Acid Assay is a homogeneous assay based on the enzyme ()-galactosidase, which has been genetically engineered into two inactive fragments termed enzyme donor (ED) and enzyme acceptor (EA). These fragments spontaneously re-associate to form fully active enzymes that, in assay format, cleave a substrate, generating a color change that can be measured spectrophotometrically. The assay consists of a set of four reagents: Enzyme Acceptor Buffer, Enzyme Acceptor Reagent, Enzyme Donor Buffer, and Enzyme Donor Reagent. A two-level (Low and High) set of calibrators is used to calibrate the assay. A three-level set of controls (1 through 3) is used for quality control of the assay.

The SIRO method is an in vitro diagnostic test for the quantitative measurement of Sirolimus in human whole blood on the Dimension® clinical chemistry system. Measurements of Sirolimus are used as an aid in the management of sirolimus therapy in renal transplant patients. The Sirolimus Calibrator is an in vitro diagnostic product for the calibration of Sirolimus (SIRO) on the Dimension® clinical chemistry system.

The automated Dimension® SIRO method uses an immunoassay technique in which free and sirolimus-bound antibody-enzyme conjugates are separated using magnetic particles. The assay is performed using a method specific Flex® reagent cartridge. The Flex® cartridge contains a pretreatment reagent, antibody-B-galactosidase conjugate, sirolimus immobilized on chromium dioxide particles, chlorophenol red ß-d-galactopyranoside (CPRG) substrate, and diluent to hydrate the tablets. To perform the SIRO assay, a sample cup (or SSC) containing the whole blood sample to be analyzed and a SIRO Flex® reagent cartridge are placed appropriately on the Dimension® system. The Dimension® system mixes and lyses the whole blood sample. The lysed sample is then mixed with the antibody enzyme conjugate. The sirolimus present in the sample is bound by the sirolimus antibody conjugate reagent. Magnetic particles coated with sirolimus are added to bind free (unbound) antibody-enzyme conjugate. The reaction mixture is then separated magnetically. Following separation, the supernatant containing the sirolimus-antibody-enzyme complex is transferred to another cuvette and mixed with the substrate. B-galactosidase catalyzes the hydrolysis of CPRG (chlorophenol red ß-d-galactopyranoside) to produce CPR (chlorophenol red) that absorbs light maximally at 577 nm. The change in absorbance at 577 nm due to the formation of CPR is directly proportional to the amount of sirolimus in the patient's sample and is measured using a bichromatic (577, 700 nm) rate technique. The Dimension® Sirolimus Calibrator (DC306) is an in-vitro diagnostic product intended to be used to calibrate the Dimension® Sirolimus method. It is a frozon liquid product packaged as a single vial for each of five levels. The matrix is human whole blood hemolysate with preservatives. Levels 2, 3, 4, and 5 contain sirolimus drug at target values of 5, 10, 20, and 31.5 ng/mL, respectively. Level 1 is a human whole blood hemolysate that does not contain sirolimus drug.

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

The ARCHITECT Sirolimus assay is a delayed one-step immunoassay for the quantitative determination of sirolimus 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, heated, and centrifuged. The supernatant is decanted into a Transplant Pretreatment Tube, which is placedonto the ARCHITECT i System. Sample, assay diluent, and anti-sirolimus coated paramagnetic microparticles are combined to create a reaction mixture. Sirolimus present in the sample binds to the anti-sirolimus coated microparticles. After a delay, sirolimus acridinium-labeled conjugate is added to the reaction mixture. The sirolimus acridinium-labeled conjucate competes for the available binding sites on the anti-sirolimus coated paramagnetic microparticles. Following an incubation, the microparticles are washed, and 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 sirolimus in the RLUs detected by the ARCHITECT i System optics.

The IMx Sirolimus assay is an in vitro reagent system for the quantitative determination of sirolimus in human whole blood as an aid in the management of renal transplant patients receiving sirolimus therapy. The IMx® Sirolimus Calibrators are for the calibration of the IMx Analyser when used for the quantitative determination of sirolimus in human whole blood. The IMx® Sirolimus MODE 1 Calibrator is for the adjustment of the stored calibration of the IMx Analyser when used for the quantitative determination of sirolimus in human whole blood. The IMx® Sirolimus Controls are for the verification of the calibration of the IMx Analyser when used for the quantitative determination of sirolimus in human whole blood. The IMx Sirolimus Whole Blood Precipitation Reagent is for the extraction of sirolimus from samples (whole blood patient specimens, IMx® Sirolimus Calibrators and Controls) to be tested on the IMx® Sirolimus assay.

Microparticle Enzyme Immunoassay (MEIA) for use on Abbott IMx® system. Assay procedure: - Incubate the sample with the anti-sirolimus antibody-coated microparticles. - Add sirolimus alkaline phosphatase conjugate and incubate. - Transfer to matrix cell. - Wash to remove unbound substances. - Add substrate. - Measure fluorescent product.