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The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. The Access CK-MB assay is a two-site immunoenzymatic ("sandwich") assay. Patient sample is added to a reaction vessel with mouse monoclonal anti-human CK-MB antibody-alkaline phosphatase conjugate and paramagnetic particles coated with mouse monoclonal anti-human CK-BB. Human serum CK-MB binds to the anti-CK-MB conjugate and is immobilized on the paramagnetic particle coated with anti-CK-BB. The CK-MB in the human serum or plasma binds to the immobilized anti-CK-BB on the solid phase by the sub-unit B epitope (common to CK-BB and CK-MB isoforms), while the mouse anti-CK-MB conjugate reacts specifically with the serum or the plasma CK-MB (no reaction with CK-MM or CK-BB isoforms). After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.

Rx ONLY For in vitro diagnostic use only. For the quantitative measurement of CK-MB in human serum and plasma (EDTA or heparin) using the VITROS 3600 Immunodiagnostic System. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

The VITROS Immunodiagnostic Products CK-MB assay is performed using the VITROS CK-MB Reagent Pack and the VITROS CK-MB Calibrators on the VITROS Systems. The current VITROS Immunodiagnostic Products CK-MB assay is susceptible to interference from biotin. Ortho has made a modification to the manufacturing process to allow the biotinylated antibody capture conjugate to be pre-bound to the well, thus mitigating the risk of biotin interference. The modified product utilizes all the same antibodies and raw materials with the exception of the addition of 0.7% Tween 20 and an increase in EDTA concentration from 0.001M to 0.030M, both of these modifications are to improve serum/plasma agreement which required a conversion factor in the previously cleared product. An immunometric immunoassay technique is used, which involves the reaction of CK-MB present in the sample with a microwell coated with biotinylated Antibody (Mouse monoclonal anti-CK-BB bound to Streptavidin), and a Horseradish Peroxidase (HRP)-labeled antibody conjugate (Mouse monoclonal anti-CK-MB). Unbound (HRP)-labeled anti-CK-MB antibody conjugate is removed by washing. The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent, is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the system. The amount of CK-MB conjugate bound is directly proportional to the concentration of CK-MB present in the sample.

The CKMB Test is an in vitro diagnostic assay for the quantitative determination of creatine kinase isoform MB in EDTA or lithium heparin whole-blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is intended for use as an aid in the diagnosis of myocardial infarction. The Myo Test is an in vitro diagnostic assay for the quantitative determination of myoglobin in EDTA or lithium heparin whole-blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is intended for use as an aid in the rapid diagnosis of heart disease, for example, acute myocardial infarction. For in vitro diagnostic use. The AQT90 FLEX analyzer is an immunoassay instrument based on the quantitative determination of time-resolved fluorescence to estimate the concentrations of clinically relevant markers on whole-blood and plasma specimens to which a relevant anticoagulant has been added. It is intended for use in point-of-care and laboratory settings.

The AQT90 FLEX is a cartridge-based immunoassay analyzer, based on time-resolved fluorescence using a europium (Eu) chelate as the fluorescent label. The test receptacles for the assay are test cups, which contain the antibodies used for capture of the analyte, and the Eu chelate labeled antibodies used to trace the captured analyte. The sample is added to the test cup together with assay buffer. The cup is then incubated to allow formation of the immuno-complex, and subsequently washed to remove unbound antibodies and sample material. Finally, the cup is exposed to excitation light, and after a delay the emitted light generated by the fluorescent label is measured by single photon counting. The total count is then compared to an assay calibration curve to obtain a quantitative measurement of the analyte's concentration in the sample. This technology uses dried reagents deposited in the test cups and in the calibration adjustment cups – no liquids other than the sample itself together with the assay buffer are required.

AQT90 FLEX CKMB Test is an in vitro diagnostic assay for the quantitative determination of creatine kinase isoform MB in EDTA or lithium-heparin whole blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is intended for use as an aid in the diagnosis of myocardial infarction. AQT90 FLEX CKMB CAL cartridge is for in vitro diagnostic use for the calibration of the CKMB Test on the AQT90 FLEX analyzer by establishing points of reference to estimate CKMB values. AQT90 FLEX LQC Multi-CHECK, Levels 1-3, is for in vitro diagnostic use. For use with the AQT90 FLEX analyzer as a liquid quality control serum (LQC) to monitor the precision of laboratory testing procedures for the analytes listed on the specification insert.

The AOT90 FLEX is a cartridge-based immunoassay, based on time-resolved fluorescence using a europium (Eu) chelate as the fluorescent label. The test receptacles for the assay are 300 µL test cups, which contain the antibodies used for capture of the analyte, and the Eu chelate labeled antibodies used to trace the captured analyte. The sample is added to the test cup together with assay buffer. The cup is then incubated to allow formation of the immuno-complex, and subsequently washed to remove unbound antibodies and sample material. Finally, the cup is exposed to excitation light, and after a delay the emitted light generated by the fluorescent label is measured by single photon counting; this measurement cycle is repeated up to 3,300 times. The total count is then compared to an assay calibration curve to obtain a quantitative measurement of the analyte's concentration in the sample. This technology uses dried reagents deposited in the test cups and in the calibration adjustment cups - no liquids other than the sample itself together with the assay buffer are required. Total assay time is less than 20 minutes.

PATHFAST CK-MB-II test is an in vitro diagnostic test for the quantitative measurement of creatine kinase-MB in heparinized or EDTA whole blood and plasma. Measurements of CK-MB are used in the aid of diagnosis of acute myocardial infarction. This method is for use in clinical laboratory or point of care (POC) settings. The kit includes the reagent cartridges and calibrators. PATHFAST Myo-II test is an in vitro diagnostic test for the quantitative measurement of myoglobin in heparinized or EDTA whole blood and plasma. Measurements of myoglobin are used to assist in the aid of diagnosis of myocardial infarction (MI). This method is for use in clinical laboratory or point of care (POC) settings. The kit includes the reagent cartridges and calibrators.

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The Stratus® CS Acute Care™ CKMB method is an in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine N-Phosphostransferase, E.C. No 2.7.3.2) in heparinized plasma. Measurements of CKMB can be used in the diagnosis and treatment of myocardial infarction and progressive, Duchenne-type muscular dystrophy. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings. The Stratus® CS Acute Care™ CKMB Calibrator (CKMB CalPak) is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care™ CKMB method. The Stratus® CS Acute Care™ CKMB Dilution Pak (CKMB DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ CKMB TestPak for the measurement of samples with elevated levels of CKMB. The Stratus® CS Acute Care™ Troponin I method (cTnl) is an in vitro diagnostic assay for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as an aid in the diagnosis of acute myocardial infarction (AMI). Cardiac troponin I can also be used as aid in the risk stratification of patients with acute coronary syndromes (ACS) with respect to their relative risk of mortality. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings. The Stratus® CS Acute Care™ Troponin I Calibrator (cTnI CalPak) is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care™ Troponin I method. The Stratus® CS Acute Care™ Troponin I Dilution Pak (cTnI DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ cTnI TestPak for the measurement of samples with elevated levels of cardiac Troponin I. The Stratus® CS Acute Care™ Myoglobin method (MYO) is an in vitro diagnostic assay for the measurement of myoglobin in heparinized plasma. Measurements of myoglobin aid in the rapid diagnosis of renal or heart disease, e.g. myocardial infarction. This method is for use by trained health care professionals in the clinical laboratory and point of care (POC) settings. The Stratus® CS Acute Care™ Myoglobin Calibrator (MYO CalPak) is an in vitro diagnostic product intended to be used for calibration of the Stratus® CS Acute Care™ myoglobin method. The Stratus® CS Acute Care™ Myoglobin Dilution Pak (MYO DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ MYO TestPak for the measurement of samples with elevated Myoglobin levels.

The Stratus® CS Acute Care™ CKMB method is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology. In this procedure, dendrimer linked monoclonal antibody is added to the center portion of a square piece of glass fiber paper in the CKMB TestPak. Sample is then added onto the paper where it reacts with the immobilized antibody. After a short incubation, a conjugate consisting of enzyme-labeled monoclonal antibody directed against a distinct antigenic site on the B subunit of the CKMB molecule is pipetted onto the reaction zone of the paper. During this second incubation period, enzyme-labeled antibody reacts with the bound CKMB, forming an antibody-antigen-labeled antibody sandwich. The unbound labeled antibody is later eluted from the field of view of the Stratus® CS analyzer by applying a substrate wash solution to the center of the reaction zone. By including substrate for the enzyme within the wash solution, initiation of enzyme activity occurs simultaneously with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of CKMB in the sample. The reaction rate is measured by an optical system that monitors the reaction rate via front surface fluorescence. All data analysis functions are performed by the microprocessor within the analyzer. The Stratus® CS Acute Care CKMB calibrator (CKMB CalPak) is a refrigerated liquid product containing human heart CKMB in a buffered bovine protein matrix with stabilizers and preservative. The kit consists of five CalPaks at a single calibrator level. Each CalPak contains calibrator reagent in three wells. The Stratus® CS Acute Care CKMB Diluent (CKMB DilPak) is a refrigerated liquid product containing buffered human protein matrix with stabilizers and 0.2% sodium azide. The kit consists of 5 DilPaks with diluent in one well. The Stratus® CS Acute Care™ Troponin I method is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology. In this procedure, dendrimer linked monoclonal antibody is added to the center portion of a square piece of glass fiber paper in the c TnI TestPak. This antibody recognizes a distinct antigenic site on the cardiac troponin I molecule. Sample is then added onto the paper where it reacts with the immobilized antibody. After a short incubation, a conjugate consisting of enzyme-labeled monoclonal antibody directed against a second distinct antigenic site on the cardiac troponin I molecule is pipetted onto the reaction zone of the paper. During this second incubation period, enzyme-labeled antibody reacts with the bound cardiac troponin I, forming an antibody-antigen-labeled antibody sandwich. The unbound labeled antibody is later eluted from the field of view of the Stratus® CS analyzer by applying a substrate wash solution to the center of the reaction zone. By including substrate for the enzyme within the wash solution, initiation of enzyme activity occurs simultaneously with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of cardiac troponin I in the sample. The reaction rate can then be measured by an optical system that monitors the reaction rate via front surface fluorescence. All data analysis functions are performed by the microprocessor within the analyzer. The Stratus® CS Acute Care Troponin I calibrator (cTnI CalPak) is a frozen liquid product containing native, human troponin complex, in a human serum base with less than 0.1% sodium azide. The kit consists of five CalPaks at a single calibrator level. Each CalPak contains calibrator reagent in three wells. The Stratus® CS Acute Care Troponin I Diluent (cTnI DilPak) is a refrigerated liquid product containing a buffered human protein matrix with stabilizers and less than 0.1% sodium azide. The kit consists of 5 DilPaks with diluent in one well. The Stratus® CS Acute Care™ MYO method is a two-site sandwich assay based upon solid phase Radial Partition Immunoassay (RPIA) technology. In this procedure, dendrimer linked monoclonal myoglobin antibody is added to the center portion of a square piece of glass fiber paper in the MYO TestPak. This antibody recognizes a distinct antigenic site on the myoglobin molecule. Sample is then added onto the paper where it reacts with the immobilized antibody. After a short incubation, a conjugate consisting of enzyme-labeled monoclonal antibody directed against a second distinct antigenic site on the myoglobin molecule is pipetted onto the reaction zone of the paper. During this second incubation period, enzyme-labeled antibody reacts with the bound myoglobin, forming an antibody-antigen-labeled antibody sandwich. The unbound labeled antibody is later eluted from the field of view of the Stratus® CS analyzer by applying a substrate wash solution to the center of the reaction zone. By including substrate for the enzyme within the wash solution, initiation of enzyme activity occurs simultaneously with the wash. The enzymatic rate of the bound fraction increases directly with the concentration of myoglobin in the sample. The reaction rate can then be measured by an optical system that monitors the reaction rate via front surface fluorescence. All data analysis functions are performed by the microprocessor within the analyzer. The Stratus® CS Acute Care MYO calibrator (MYO CalPak) is a refrigerated liquid product containing human heart myoglobin in a bovine albumin matrix with stabilizers and less than 0.1 % sodium azide. The kit consists of five CalPaks at a single calibrator level. Each CalPak contains calibrator reagent in three wells. The Stratus® CS Acute Care MYO Diluent (MYO DilPak) is a refrigerated liquid product containing a buffered bovine protein matrix with stabilizers and 0.2 % sodium azide. The kit consists of 5 DilPaks with diluent in one well.

ARCHITECT STAT CK-MB is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of CK-MB in human serum and plasma on the ARCHITECT i System with STAT capability. CK-MB values are used to assist in the diagnosis of myocardial infarction (MI).

The ARCHITECT STAT CK-MB assay is a two-step assay to determine the presence of the MB isoenzyme of creatine kinase (CK-MB) in human serum and plasma using CMA technology with flexible assay protocols, referred to as Chemiflex®. In the first step, sample and anti-CK-MB coated paramagnetic microparticles are combined. After incubation and washing, anti-CK-MB acridinium conjugate is added in the second step. Following another incubation and wash, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of CK-MB in the sample and the RLUs detected by the ARCHITECT i* optical system.

The RAMP CK-MB Assay is a quantitative immunochromatographic test indicated for use as an in vitro diagnostic product used with the RAMP Clinical Reader to measure CK-MB levels in EDTA whole blood. Measurement of CK-MB aids in the rapid diagnosis of acute myocardial infarction (AMI). The RAMP CK-MB Assay is not intended to monitor reperfusion patients. The RAMP CK-MB Assay is intended to be used only to prioritize patient management for those suspected of AMI.

The RAMP CK-MB Assay is a quantitative immunochromatographic test for the determination of CK-MB levels in EDTA whole blood. Diluted EDTA whole blood is added to the sample well of the Test Cartridge which houses the immunochromatographic test strip. The red blood cells are retained in the sample pad, and the separated plasma migrates along the strip. Fluorescent-dyed latex particles coated with anti-CK-MB antibodies bind to CK-MB, if present in the sample. As the sample migrates along the strip, CK-MB bound particles are immobilized at the detection zone, and additional particles are immobilized at the internal control zone. The RAMP Reader then measures the amount of fluorescence emitted by the complexes bound at the detection zone and at the internal control zone. Using a ratio between the two fluorescence values, a quantitative reading is calculated.

The IMMULITE 2500 CK-MB is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction. The IMMULITE 2500 Myoglobin is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of myoglobin in serum and heparinized plasma, as an aid in the diagnosis of acute myocardial infarction (AMI). The IMMULITE 2500 STAT Troponin I is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).

IMMULITE 2500 CK-MB is a solid-phase, two-site IMMULITE chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer. IMMULITE 2500 Myoglobin is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer. IMMULITE 2500 STAT Troponin I is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.

The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum and plasma using the Access Immunoassay Systems. Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction.

The Access CK-MB reagents, calibrators, and the Access Immunoassay Analyzers (Access, Access 2, and Synchron LXi 725) comprise the Access Immunoassay Systems for the quantitative determination of CK-MB in human serum and plasma.