Image: The Lumipulse G CK-MB immunoassay, an aid in the diagnosis of acute myocardial infarction, being prepared to run on a LUMIPULSE G1200 instrument (Photo courtesy of Fujirebio Europe).
Creatine Kinase (CK) is an enzyme found in high amounts in muscle tissue due to its role in muscle contraction. CK-MB is found mainly in cardiac muscle, where it comprises 15%-40% of the total CK activity, with the remainder being CK-MM.
Trace amounts of CK-MB are found in skeletal muscle (2%-3% of the total CK activity); therefore, patients with skeletal muscle injury will have increases in the absolute concentrations of CK and CK-MB. Furthermore, release of CK-MB only occurs upon death of myocardial cells and it is not released in the setting of ischemia. CK-MB was therefore considered to be the most useful biomarker for detection of myocardial injury before the introduction of high sensitivity Troponin assays.
Fujirebio Europe (Ghent, Belgium) announced the CE marking of the Lumipulse G CK-MB immunoassay, which can be used as an aid in the diagnosis of Acute Myocardial Infarction (AMI) or as a marker of re-infarction. The launch of this assay now completes the Lumipulse G Cardiac panel which also includes brain natriuretic peptide (BNP), high sensitivity Troponin I and Myoglobin. The assay utilizes proven Chemiluminescent Enzyme Immunoassay (CLEIA) technology with results that are available in up to 35 minutes. The immunoreaction cartridges are used for in vitro diagnostic use with the LUMIPULSE G instruments for the quantitative measurement of the MB iso-enzyme of the creatine kinase (CK-MB) in human serum or plasma.
Christiaan De Wilde, CEO of Fujirebio Europe, said, “We know that robust assay performance is crucial for clinicians facing the difficult and complex diagnosis of AMI. Building on the robust and reliable Lumipulse G platform, our panel of cardiac assays provides high sensitivity, high precision and a wide dynamic range. These are key factors that ensure you get the right result when time is limited. Added to this, our unique single test cartridge concept helps eliminate reagent waste for cardiac markers such as CK-MB and Myoglobin, assays that will tend to be run in lower volumes.”