For in vitro diagnostic use. Others Elecsys CK-MB STAT IVD Elecsys® CK-MB STAT CPS_000455 USA ONLY:Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma.Measurements of the MB isoenzyme of creatinine kinase are used as an aid in the diagnosis of myocardial infarction.The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers.GLOBAL:Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma.The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers. en USA ONLY:Creatine kinase (CK) is a dimeric enzyme which occurs in four different forms: a mitochondrial isoenzyme and the cytosolic isoenzymes CK‑MM (muscle type), CK‑BB (brain type) and CK‑MB.1,2The determination of CK‑MB mass in serum is an important element in the diagnosis of myocardial ischemia, e.g. in acute myocardial infarction, myocarditis, etc.1,2 CK‑MB is detectable in the blood about 3‑8 hours after the onset of cardiac symptoms and can remain detectable over a lengthy period of time, depending on the course of the condition.1Elevated CK‑MB is not specific for MI (myocardial infarction) and may be detected in other disease states.3 Elevated CK‑MB values should be interpreted in conjunction with clinical presentation and medical history.The sensitivity of a CK‑MB determination is dependent upon the time at which a sample was taken. Follow‑up assays are therefore meaningful.1,4The Elecsys CK‑MB STAT assay employs two different monoclonal antibodies directed against human CK‑MB.1 Rozenman Y, Gotsman MS. The earliest diagnosis of acute myocardial infarction. Annu Rev Med 1994;45:31-44.2 Adams JE, Abendschein DR, Jaffe AS. Biochemical markers of myocardial injury: Is MB creatine kinase the choice for the 1990s? Circulation 1993;88:750-763.3 Ay H, Arsava EM, Saribas O. Creatine Kinase-MB Elevation After Stroke is not cardiac in origin. Stroke 2002;(33)286-289.4 Apple FS. Diagnostic markers for detection of acute myocardial infarction and reperfusion. Laboratory Medicine 1992;23(5):297-322.GLOBAL:Creatine kinase (CK) is a dimeric enzyme which occurs in four different forms: a mitochondrial isoenzyme and the cytosolic isoenzymes CK‑MM (muscle type), CK‑BB (brain type) and CK‑MB.1,2The determination of CK‑MB mass in serum is an important element in the diagnosis of myocardial ischemia, e.g. in acute myocardial infarction, myocarditis, etc.1,2 CK‑MB is detectable in the blood about 3‑8 hours after the onset of cardiac symptoms and can remain detectable over a lengthy period of time, depending on the course of the condition.1CK‑MB may also appear in other clinical conditions, e.g. in rhabdomyolysis and stroke.1,4 Within the scope of laboratory diagnostics, the determination of total CK, troponin T and/or myoglobin can contribute to the differentiation of these clinical pictures. Because of their higher sensitivity and specificity, cardiac troponins, measured by high-sensitivity assays, are the preferred biomarkers to define myocardial infarction,3 and if a troponin assay is not available, the best alternative is CK-MB measured by a mass assay.3The sensitivity of a CK‑MB determination is dependent upon the time at which a sample was taken. Follow-up assays are therefore meaningful.1,5The Elecsys CK‑MB assay employs two different monoclonal antibodies directed against human CK‑MB.1 Rozenman Y, Gotsman MS. The earliest diagnosis of acute myocardial infarction. Annu Rev Med 1994;45:31-44.2 Adams JE, Abendschein DR, Jaffe AS. Biochemical markers of myocardial injury: Is MB creatine kinase the choice for the 1990s? Circulation 1993;88:750-763.3 Thygesen K, Alpert JS, Jaffe AS, et al. Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infaction. Fourth Universal Definition of Myocardial Infarction. Glob Heart 2018;13(4):305-338.4 Ay H, Arsava EM, Saribas O. Creatine Kinase-MB Elevation After Stroke is not cardiac in origin. Stroke 2002;(33)286-289. 5 Apple FS. Diagnostic markers for detection of acute myocardial infarction and reperfusion. Laboratory Medicine 1992;23(5):297-322. en Sandwich principle. Total duration of assay: 9 minutes.cobas e 411 analyzer:1st incubation: 15 μL of sample, a biotinylated monoclonal anti‑CK‑MB antibody, and a monoclonal CK‑MB‑specific antibody labeled with a ruthenium complexa) react to form a sandwich complex.2nd incubation: After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin.cobas e 601 and cobas e 602 analyzers:During a 9 minute incubation, antigen in the sample (15 μL), a biotinylated monoclonal anti‑CK‑MB antibody, a monoclonal CK‑MB‑specific antibody labeled with a ruthenium complex and streptavidin-coated microparticles react to form a sandwich complex, which is bound to the solid phase.All analyzers:The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell/ProCell M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier.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 or e‑barcode.a) Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy) en

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