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For in vitro diagnostic use with the IMMULITE® 2000 Analyzer -- for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders. The test results are to be used in conjunction with clinical findings and other laboratory tests.

IMMULITE® 2000 3gAllergy™ Specific IgE is a solid-phase, two-step, chemiluminescent immunoassay that exploits liquid phase kinetics in a bead format. It represents a significant advance over conventional methods relying on allergens attached to a solid-phase support, such as a paper disk. The allergens are covalently bound to a soluble polymer matrix, which in turn is labeled with a ligand. The use of an amino acid co-polymer amplifies the amount of allergen that the matrix can support. Incubation Cycles: 2 × 30 minutes.

For in vitro diagnostic use with the IMMULITE® 2000 Analyzer - for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders.

IMMULITE® 2000 3gAllergy™ Specific IgE is a solid-phase, two-step, chemiluminescent immunoassay that exploits liquid phase kinetics in a bead format. It represents a significant advance over conventional methods relying on allergens attached to a solid-phase support, such as a paper disk. The allergens are covalently bound to a soluble polymer matrix, which in turn is labeled with a ligand. The use of an amino acid co-polymer amplifies the amount of allergen that the matrix can support. Incubation Cycles: 2 × 30 minutes.

The ADVIA® Chemistry Hemoglobin A1c method is for in vitro diagnostic use in the quantitative determination of Hemoglobin A1c, a diabetes marker, in whole blood on the ADVIA Chemistry systems. Such measurements are used for monitoring the long-term glycemic control of persons with diabetes. The A1c and total hemoglobin (tHb) values generated as part of the HbA1cN and HbA1cI results are intended for use in the calculation of the A1c / total hemoglobin ratio, and must not be used individually for diagnostic purposes. *Note: HbA1cN reports HbA1c in % and HbA1cI reports HbA1c in mmol/mol The ADVIA® Chemistry A1c Calibrators are for in vitro diagnostic use in the calibration of the A1c and total hemoglobin methods (Automated and Manual Pretreatment) on the ADVIA Chemistry Systems.

The concentration of A1c and the concentration of total hemoglobin are measured and the ratio is reported (either as % or mmol/mol). There are two different sample pretreatment methods available on the ADVIA Chemistry System. The first method is an Automated Pretreatment that uses 4 reagents: A1c Denaturant Reagent, Total Hemoglobin Reagent (tHb 2), A1c Agglutinator Reagent (R1) and A1c Antibody Reagent (R2). In this Automated Pretreatment step, the whole blood sample is mixed with the A1c Denaturant Readent. The red blood cells are lysed and the hemoglobin chains are hydrolyzed by the protease present in the reagent. The second method is a Manual Pretreatment that uses the same reagents as the first method except that the A1c Denaturant Reagent is replaced with the Hemoglobin Denaturant Reagent. For this method, there is an off-line pretreatment that is followed bv a 10 minute incubation. For the measurement of total hemoglobin, the Total Hemoglobin Reagent is used. The method is based on the conversion of all hemoglobin derivatives into alkaline hematin in an alkaline solution of a nonionic detergent A latex agglutination inhibition method is used for the measurement of specific A1c. The A1c present in the sample competes with the agglutinator (synthetic latex containing multiple copies of the immunoreactive portion of A1c) for the anti-A1c antibody; thereby reducing the rate of agglutination. A concentration curve is obtained by monitoring the change in scattered light as a change of absorbance. The actual change in absorbance is inversely proportional to the concentration of A1c in the sample. The HbA1cN NGSP result (%) or the HbA1cl IFCC result (mmol/mol) is calculated using the A1c and total hemoglobin values. The ADVIA® Chemistry A1c Calibrators are used to calibrate the methods. The calibrators consist of four (4) levels of lyophilized whole blood containing varying concentrations of HbA1c and total hemoglobin. There is a single level calibration for total hemoglobin (Cal 1) and a multi-level calibration (six levels) for A1c. Four calibrator levels (designated Cal 1 - 4) are provided in a single kit and each level is 0.5 g/vial. The other two levels consist of Saline (Cal 0) and Cal 5 (prepared by the system from Cal 4 using 1.4 times the volume used for Cal 4). The target value of each calibrator (calibration) level is: - Calibration Level 1 (Cal 0): 0.00 umol/L A1c, 0.0 g/dL Total Hemoglobin ● - Calibration Level 2 (Cal 1): 2.30 µmol/L A1c, 11.0 g/dL Total Hemoglobin . - Calibration Level 3 (Cal 2): 3.65 umol/L A1c . - Calibration Level 4 (Cal 3): 5.15 umol/L A1c . - Calibration Level 5 (Cal 4): 6.80 umol/L A1c . - Calibration Level 6 (Cal 5): 8.20 umol/L A1c

The ADVIA Centaur Cyclosporine assay is an in vitro diagnostic immunoassay for the quantitative determination of cyclosporine in human whole blood using the ADVIA Centaur systems. This assay is intended for use as an aid in the management of cyclosporine therapy in kidney, heart, and liver transplant patients.

The ADVIA Centaur® Cyclosporine assay is a competitive immunoassay using direct chemiluminescent technology. Cyclosporine in the patient sample competes with acridinium ester-labeled cyclosporine in the Lite Reagent for a limited amount of biotin-labeled monoclonal mouse anti-cyclosporine antibody. Biotinlabeled anti-cyclosporine binds to streptavidin that is covalently coupled to paramagnetic particles in the Solid Phase. In the ADVIA Centaur® Cyclosporine assay the sample is manually pretreated to lyse the cells and solubilize the cyclosporine. An inverse relationship exists between the amount of cyclosporine present in the patient sample and the amount of relative light units (RLUs) detected by the system.

The neonatal bilirubin test intended use on the Rapidlab 1245 and Rapidlab 1265 analyzers is an in vitro diagnostic test for the determination of total neonatal bilirubin (nBili) concentration in the whole blood of newborn infants. Measurement of nBili aids in assessing the risk of kernicterus.

Neonatal Bilirubin (nBili) is a new parameter enabled on models 1245 and 1265 of the Rapidlab® 1200 blood gas family of instruments. It is intended as an in vitro diagnostic test for the determination of total neonatal Bilirubin (nBili) concentration in the whole blood of newborn infants. Enabling the nBill measurement is accomplished through software design changes introduced in Rapidlab Software Version 2.1. No hardware /mechanical changes were needed.

The ADVIA CHEMISTRY C-Reactive Protein_2 assay is for in vitro diagnostic use in the quantitative determination of the concentration of C-Reactive Protein (CRP) in human serum and plasma (lithium heparin) on the ADVIA Chemistry systems. Such measurements are used in the evaluation of infection, tissue injury, inflammatory disorders, and associated diseases. Increases in CRP values are non-specific for many disease processes and should not be interpreted without a complete clinical evaluation. The ADVIA Chemistry C-Reactive Protein_2 Calibrators are for in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the C-Reactive Protein 2 (CRP 2) method.

The ADVIA Chemistry C-Reactive Protein_2 (CRP_2) assay is for in vitro diagnostic use in the quantitative determination of the concentration of C-Reactive Protein in human serum and plasma on the ADVIA® Chemistry systems. The ADVIA Chemistry C-Reactive Protein_2 Calibrators are used to calibrate this method. The proposed labeling indicates the ADVIA Chemistry CRP_2 reagents and Calibrators are for use on the family of ADVIA Chemistry Systems (1200 / 1650 / 1800 / 2400). The CRP_2 latex reagent is a suspension of uniform polystyrene latex particles coated with rabbit anti-CRP antibody. When serum or plasma containing CRP is mixed with the latex reagent, agglutination takes place resulting in an increase in the turbidity. This turbidity is measured at 571 nm. The CRP concentration in serum or plasma is determined from a calibration curve that is generated with the calibrators. The ADVIA® Chemistry C-Reactive Protein_2 Calibrators consist of six (6) levels of protein stabilized matrices containing varying concentrations of recombinant human CRP. The Calibrators have targeted expected values (lot specific) of 0, 5, 20, 40, 160, and 320 mg/L. The calibrators (1 mL/vial) and ready to use. Storage is at 2 - 8℃.

Immulite 2500 OM-MA: For in vitro diagnostic use with the IMMULITE 2500 Analyzer- for the quantitative measurement of CA125 antigen in human serum, as an aid in monitoring the response to therapy for patients with epithelial ovarian cancer and in detecting residual ovarian cancer in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures. Immulite Tumor Marker Controls: TMC is an assayed, serum-based, tri-level control containing analytes associated with malignancy which are commonly measured by immunoassay. It is intended strictly for in vitro use as an aid in monitoring the day-to-day performance of assays for these constituents.

The IMMULITE 2500 OM-MA Immunoassay is a solid-phase, two-site, chemiluminescent immunometric assay for use with the IMMULITE 2500 Automated Analyzer.

The DCA Vantage™ is a semi-automated, benchtop system. It is designed to quantitatively measure the percent Hemoglobin A1c in blood and low concentrations of albumin in urine (microalbuminuria), creatinine in urine, and the albumin/creatinine ratio in urine. The measurement of hemoglobin A1c concentration is recommended for monitoring the longterm glycemic control of persons with diabetes. Testing for microalbuminuria (low concentration of albumin in urine) is recommended in patients with insulin-dependent diabetes mellitus (IDDM) as well as patients with non-insulin dependent diabetes mellitus (NIDDM). It is intended for use in both screening for, and monitoring treatment of, microalbuminuria. Measurement of creatinine is used as a calculation basis to adjust the albumin/creatinine ratio result for varying urine concentrations. The reporting of albumin/creatinine ratio is recommended for the early detection of kidney diseases. The DCA Vantage system is for use in laboratories such as: physician office laboratories, clinics, and hospitals. Tests performed using the DCA Vantage™ are intended for in vitro diagnostic use.

The DCA Vantage is a device modification to the previously cleared DCA 2000+. It is a semi-automated, benchtop analyzer designed to quantitatively measure the percent Hemoglobin A1c (HbA1c) in blood and low concentrations of albumin in urine (microalbuminuria), creatinine in urine, and the albumin/creatinine ratio in urine. Identical to the DCA 2000+, all testing takes place at the analyzer. User steps to introduce the sample to the cartridge and the cartridge to the analyzer are unchanged. To perform a test, the user needs to collect test sample in the capillary holder, insert holder into the cartridge, scan cartridge into the barcode track, place cartridge in its compartment, remove the flexible tab and close the door to automatically start the test. Test results are displayed on screen and measurement is completed in 6-7 minutes.

The ADVIA® Chemistry Microalbumin Calibrators are for in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the ADVIA Chemistry Microalbumin method is used for in vitro quantitation of albumin in urine). The ADVIA® Chemistry Microalbumin 2 Calibrators are for in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the ADVIA Chemistry Microalbumin 2 method (this method is used for in vitro quantitation of albumin in urine).

The ADVIA® Chemistry Microalbumin Calibrators and ADVIA® Chemistry Microalbumin 2 Calibrators are each 5 level liguid aqueous buffered solutions containing varying concentrations of purified human serum albumin. The Microalbumin Calibrators have expected values (lot specific) of 1, 2.5, 5, 10, and 20 mg/dL, and the Microalbumin 2 Calibrators have expected values (lot specific) of 1, 4, 10, 20, and 40 mg/dlL. The calibrators (2 mL/vial) are liquid and ready to use. Storage is at 2 - 8℃.

For in vitro diagnostic use in the quantitative determination of creatinine in human serum, plasma, and urine on the ADVIA Chemistry Systems. Such measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis.

The ADVIA Chemistry Enzymatic Creatinine_2 is used for the in vitro quantitative determination of creatinine in human serum, plasma and urine on the ADVIA® Chemistry Systems. The proposed labeling indicates the ADVIA Chemistry Enzymatic Creatinine 2 reagents can be used on the ADVIA Chemistry 1200 / 1650 / 1800 / 2400 Systems. The principle of the method is based on the enzymatic method employing creatininase, creatinase, sarcosine oxidase, horseradish peroxidase and N-(3-sulfopropy))-3methoxy-5-methylaniline (HMMPS) as the color agent. When a sample is mixed with Reagent 1 and Reagent 2, creatinine in the sample is converted to creatine by the action of creatininase. The creatine formed is hydrolyzed by creatinase to produce sarcosine and urea. The sarcosine is then decomposed by sarcosine oxidase to form glycine, formaldehyde and hydrogen peroxide. In the presence of peroxidase (POD), the hydrogen peroxide formed yields a blue pigment by quantitative oxidative condensation with N-(3-sulfopropy)-3-methoxy-5-methylaniline (HMMPS) and 4aminoantipyrine. The creatinine concentration is obtained by measuring the absorbance of blue color. The increase in optical absorbance is determined as an endpoint assay, which is proportional to the concentration of creatinine in the sample.